Accessories, Arthroscopic
Orthopedic · 21 CFR 888.1100
Recent MDR events
5,126 adverse event reports on file
- UNKJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04154
- FIRSTPASS MINI STRAIGHTJul 30, 2026MalfunctionArthrocare Corporation3006524618-2026-00400
- FIRSTPASS MINI STRAIGHTJul 30, 2026MalfunctionArthrocare Corporation3006524618-2026-00401
- DRILL 2.5MM W/3.5MM SHST FORJul 29, 2026MalfunctionSmith & Nephew, Inc.1219602-2026-02372
- MITEK OBTURATOR BUTTON 4.0Jul 28, 2026MalfunctionMedos International Sã rl1221934-2026-03300
- MITEK DUAL STOPCOCK SHEATHJul 28, 2026MalfunctionMedos International Sã rl1221934-2026-03301
- AWL-DILATOR TWINFIX ULTRA 4.5MMJul 28, 2026InjurySmith & Nephew, Inc.1219602-2026-02333
- FIRSTPASS MINI STRAIGHTJul 27, 2026MalfunctionArthrocare Corporation3006524618-2026-00389
- ARTHRO PUSHER/CUTTERJul 27, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03259
- ARTHRO PUSHER/CUTTERJul 27, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03260
Event type breakdown
Recalls
55 recall events for this product code
- Stryker CorporationTerminatedJun 3, 2016
Stryker FlowPort II Adapter: Model number: 00CAT00778
Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction
Z-1910-2016 · View FDA record ↗ - Smith & Nephew, Inc., Endoscopy Div.TerminatedJan 29, 2016
Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Z-0700-2016 · View FDA record ↗ - Ceterix Orthopedics, Inc.TerminatedNov 9, 2015
NovoCut Suture Manager; Ceterix catalog number CTX-001.
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Z-0250-2016 · View FDA record ↗ - Surgical Instrument Service And Savings, Inc.TerminatedJul 1, 2013
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Z-1641-2013 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.TerminatedMay 9, 2013
DePuy Mitek Tissue Liberator -Blade Up
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Z-1278-2013 · View FDA record ↗ - Instratek, IncorporatedTerminatedMar 8, 2013
Endotrig Trigger Release Sterile Micro Hook Blade
Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.
Z-0922-2013 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedMar 19, 2012
Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR Syste
The firm received several complaints from customers reporting that the blade of the EGR system may not retract back into the device following surgery. The firm attributes this problem to user error or improper surgical technique on the part of the physician.
Z-1226-2012 · View FDA record ↗ - Smith & Nephew, Inc. Endoscopy DivisionTerminatedOct 12, 2010
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Endofemoral Aimer tip may separate due to failure of the soldered joint
Z-0040-2011 · View FDA record ↗ - Smith & Nephew, Inc. Endoscopy DivisionTerminatedOct 12, 2010
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Endofemoral Aimer tip may separate due to failure of the soldered joint
Z-0041-2011 · View FDA record ↗ - Smith & Nephew, Inc. Endoscopy DivisionTerminatedOct 12, 2010
Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Endofemoral Aimer tip may separate due to failure of the soldered joint
Z-0042-2011 · View FDA record ↗
Registered firms
328 firms currently registered for this product code
Sklar Corporation - Warehouse
Salisbury, MD, US
Medline Renewal
Redmond, OR, US
Biorad Medisys Pvt. Ltd.
Pune Maharashtra, IN
Elmed, Inc.
Glendale Heights, IL, US
Green Or Llc
Lakeville, MN, US
Pt. Transmedic Indonesia
Jakarta, ID
Biogenomics S.a.c. - Biocells Surgical
Lima, PE
Stryker Gmbh
SELZACH Solothurn, CH
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Medtronic Medical Costa Rica S.r.l.
Coyol Alajuela, CR
Parcus Medical , L.l.c.
Sarasota, FL, US
Steris Isomedix Puerto Rico, Inc.
Alts De Cerro Gordo 3&4, PR, US
Vericel Corporation
CAMBRIDGE, MA, US
Arthrocare Corporation
Coyol Alajuela, CR
Innomed, S.a. De C.v.
San Salvador, SV
Innomed, Inc.
SAVANNAH, GA, US
Leitner Ag
Busswil Bern, CH
Medtronic Distribution Center
Memphis, TN, US
Medos International Sarl
Le Locle Neuchatel, CH
Specialteam
Chino, CA, US
Riverside Machine & Engineering, Inc.
Eau Claire, WI, US
Synthes (usa) Products Llc
West Chester, PA, US
Ortosistemas, S.a.
Panama, PA
Lincotek Medical Llc
Vandalia, OH, US
Onyx Medical Llc
MEMPHIS, TN, US
510(k) clearances
2 clearances for this product code