Recalls for Reamer

Products not sterilized, sterility cannot be confirmed

Two planers were found to be unusable during sawbones shoulder training.

Non-conforming material used.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.

The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.

Investigation determined that units supplied were missing the 4x21 degree helix angle.

Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.

Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.

Bone reamer may not have a cutting surface on the tip.

Pilot shaft may break during reaming or broaching of the femur

Pilot shaft may break during reaming or broaching of the femur

Pilot shaft may break during reaming or broaching of the femur

Pilot shaft may break during reaming or broaching of the femur

Pilot shaft may break during reaming or broaching of the femur

Pilot shaft may break during reaming or broaching of the femur

There is potential to break during use.

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.