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ADTEC SOVEREIGN
Aesculap AG · Model PL231R · UDI-DI 04046964074844
HTD
Prescription
10
510(k) clearances
2,217
Adverse events (1 deaths)
14
Recalls
667
Facilities
Description
ADTEC SOVEREIGN Grasping Forceps, complete instrument, (420 mm), diam. 5 mm, with sliding ratchet, single action, reusable
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.