Passer
Orthopedic · 21 CFR 888.4540
Recent MDR events
906 adverse event reports on file
- DISP FIRSTPASS STR PASSR SELFJul 6, 2026MalfunctionArthrocare Corporation3006524618-2026-00359
- DISP FIRSTPASS STR PASSR SELFJul 6, 2026MalfunctionArthrocare Corporation3006524618-2026-00363
- DISP FIRSTPASS STR PASSR SELFJul 5, 2026MalfunctionArthrocare Corporation3006524618-2026-00354
- FIRSTPASS SUTURE PASSERJul 4, 2026MalfunctionArthrocare Corporation3006524618-2026-00350
- DISP FIRSTPASS STR PASSR SELFJun 30, 2026MalfunctionArthrocare Corporation3006524618-2026-00344
- FIRSTPASS SUTURE PASSERJun 8, 2026MalfunctionArthrocare Corporation3006524618-2026-00294
- FIRSTPASS SUTURE PASSERJun 1, 2026MalfunctionArthrocare Corporation3006524618-2026-00281
- DISP FIRSTPASS STR PASSR SELFMay 18, 2026MalfunctionArthrocare Corporation3006524618-2026-00253
- NANOPASS REACH CRESCENTMay 14, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00297
- NANOPASS REACH CRESCENTMay 14, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00298
Event type breakdown
Recalls
8 recall events for this product code
- Biomet, Inc.TerminatedMay 26, 2016
Various trauma and sports medicine instruments and implants.
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.
Z-1824-2016 · View FDA record ↗ - Biomet, Inc.TerminatedOct 9, 2014
Black Mamba Suture Passer.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Z-0056-2015 · View FDA record ↗ - Biomet, Inc.TerminatedOct 9, 2014
Green Mamba Suture Passer.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Z-0057-2015 · View FDA record ↗ - Biomet, Inc.TerminatedJun 16, 2014
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part number
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Z-1803-2014 · View FDA record ↗ - Surgical Instrument Service And Savings, Inc.TerminatedJul 1, 2013
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511
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-1636-2013 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedAug 24, 2010
REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY.
This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
Z-2245-2010 · View FDA record ↗ - Biomet, Inc.TerminatedUnknown
Black Mamba Suture Passer
There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Z-0471-2016 · View FDA record ↗ - Biomet, Inc.TerminatedUnknown
Green Mamba Suture Passer
There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Z-0472-2016 · View FDA record ↗
Registered firms
139 firms currently registered for this product code
Narang Medical, Ltd.
New Delhi, IN
Gsource, Llc.
EMERSON, NJ, US
Millennium Surgical Corp
Schaumburg, IL, US
Trimed, Inc.
Santa Clarita, CA, US
Arthrex, Inc.
Ave Maria, FL, US
Pioneer Surgical Technology, Inc.
Marquette, MI, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Systagenix Wound Management Manufacturing Limited
North Yorkshire, GB
Aesculap, Inc.
CENTER VALLEY, PA, US
Synergy Health Ast, Srl
Alajuela, CR
Hn And M Gmbh
Derendingen Solothurn, CH
Integra Lifesciences Production Corporation
Mansfield, MA, US
Suzhou Elite Precision Machinery Co., Ltd.
Kunshan Jiangsu, CN
Adler Instrument Company
Brooksville, FL, US
Anqing Changfan Medical Instrument Co., Ltd
Anqing Anhui, CN
Smith & Nephew Inc.
MANSFIELD, MA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Efinger Instruments Gmbh & Co. Kg
SPAICHINGEN Baden-Wurttemberg, DE
Smith & Nephew Inc.
ANDOVER, MA, US
Arthrex Gmbh
Munich Bavaria, DE
Addn Solutions Gmbh & Co. Kg
Wurmlingen Baden-Wurttemberg, DE
Integra Lifesciences Corporation
Princeton, NJ, US
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Auxein Medical Private Limited
Sonipat Haryana, IN
510(k) clearances
9 clearances for this product code
- Mitek ProductsMar 10, 1997
K970360 · MITEK SUTURE RETROGRADER
- Acufex Microsurgical, Inc.May 5, 1993
K923381 · SOFT TISSUE EXPANDER
- Acufex Microsurgical, Inc.May 5, 1993
K920621 · ACUFEX PASSING PINS AND SURGICAL WIRE
- Instrument Makar, Inc.Feb 9, 1989
K885311 · MENISCUS MENDER II LOOP
- Visitec Co.Oct 5, 1984
K843592 · VICO MICRO SURGICAL INSTRUMENTS
- Plastafil, Inc.Jul 11, 1984
K841622 · SOFT-TISSUE INSTRUMENT
- Plastafil, Inc.Jul 11, 1984
K841623 · SLOTTED SOFT-TISSUE INSTRUMENT
- Dow Corning Corp. Healthcare Industries MaterialsJul 10, 1981
K811679 · SILASTIC TENDON PASSER H.P.