Passer
FDA product code HWQ · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
9510(k) clearances
0PMA approvals
8recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970360 | Mitek Suture RetrograderHWQ · Traditional | Mitek Products | 03/10/1997SE |
| K923381 | Soft Tissue ExpanderHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K920621 | Acufex Passing Pins and Surgical WireHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K885311 | Meniscus Mender II LoopHWQ · Traditional | Instrument Makar, Inc. | 02/09/1989SE |
| K843592 | Vico Micro Surgical InstrumentsHWQ · Traditional | Visitec Co. | 10/05/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841622 | Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | Dow Corning Corp. Healthcare Industries Materials | 07/10/1981SE |
| K791960 | Roth-Kennedy PasserHWQ · Traditional | 3M Company | 10/04/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1824-2016 Class II | Various trauma and sports medicine instruments and implants. Passer.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-0472-2016 Class II | Green Mamba Suture PasserThere may be a separation and an insufficient weld between the spring and washer. The weld between the… | Biomet, Inc. | 12/02/2015Terminated |
| Z-0471-2016 Class II | Black Mamba Suture PasserThere may be a separation and an insufficient weld between the spring and washer. The weld between the… | Biomet, Inc. | 12/02/2015Terminated |
| Z-0057-2015 Class II | Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to…An investigation identified that high level friction may exist between the needle and Mamba suture passer… | Biomet, Inc. | 09/26/2014Terminated |
| Z-0056-2015 Class II | Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to…An investigation identified that high level friction may exist between the needle and Mamba suture passer… | Biomet, Inc. | 09/26/2014Terminated |
| Z-1803-2014 Class II | EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a…The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the… | Biomet, Inc. | 04/15/2014Terminated |
| Z-1636-2013 Class II | - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-2245-2010 | REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD…This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that… | Linvatec Corp. dba ConMed Linvatec | 01/28/2010Terminated |