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PROSPACE
Aesculap AG · Model SN003R · UDI-DI 04046963835552
HWA
Prescription
4
510(k) clearances
19,287
Adverse events
27
Recalls
303
Facilities
Description
PROSPACE PEEK IMPACTOR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-03 | Exactech, Inc. | Impactor handle may be missing cross-pin |
| 2026-02-03 | Exactech, Inc. | Impactor handle may be missing cross-pin |
| 2024-10-30 | INCIPIO DEVICES | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. |
| 2023-06-05 | Exactech, Inc. | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| 2020-05-12 | XTANT Medical | The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. |
| 2019-08-16 | Enztec Limited | The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor |
| 2019-07-24 | Exactech, Inc. | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. |
| 2017-08-28 | Zimmer Biomet, Inc. | Potential for the Persona Partial Knee Impactor Pad to fracture. |
| 2017-02-09 | Encore Medical, Lp | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titaniu |
| 2017-02-09 | Encore Medical, Lp | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titaniu |
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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.