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Medicon
Medicon eG. Chirurgiemechaniker-Genossenschaft · Model 78.26.63 · UDI-DI 04046826157838
HWQ
Prescription
9
510(k) clearances
906
Adverse events
8
Recalls
127
Facilities
Description
Bunnell tendon passer 23.0cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-01 | Biomet, Inc. | 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 |
| 2015-12-02 | Biomet, Inc. | 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 j |
| 2015-12-02 | Biomet, Inc. | 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 j |
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
| 2014-04-15 | Biomet, Inc. | The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2010-01-28 | Linvatec Corp. dba ConMed Linvatec | 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. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.