Retractor

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

Centurion Sterile Weitlaner Retractor, Reorder: 67315

Three is the potential for the retractors to puncture through the sterile packaging.

ECONO STERILE medical procedure kits labeled as:

Reports of various packaging issues that may result in a breach of the sterile barrier.

Brand Name: Fathom Pedicle-Based Retractor

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Brand Name: Fathom Pedicle-Based Retractor

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Centurion retractor kits labeled as:

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula

Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.