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GEM COUPLER Forceps
SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM4183C · UDI-DI 00844735002850
HTD
Prescription
10
510(k) clearances
2,235
Adverse events (1 deaths)
14
Recalls
667
Facilities
Description
Reusable instrument used to grasp the blood vessel and evert onto the GEM COUPLER rings.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-31 | Aesculap Inc | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2022-07-25 | Stradis Medical, LLC dba Stradis Healthcare | The sterile barrier may be compromised. |
| 2022-07-25 | Stradis Medical, LLC dba Stradis Healthcare | The sterile barrier may be compromised. |
| 2019-01-09 | ConvaTec, Inc | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. |
| 2018-11-02 | Baxter Healthcare Corporation | Potential presence of rust on Coupler Forceps (GEM4183C). |
| 2013-11-26 | Biomet, Inc. | Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium. |
| 2013-11-20 | Edwards Lifesciences, LLC | Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control con |
| 2009-09-03 | Synthes USA (HQ), Inc. | The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification. |
| 2009-09-03 | Synthes USA (HQ), Inc. | The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification. |
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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.