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P.C.A.
Howmedica Osteonics Corp. · Model 6728-2-940 · UDI-DI 04546540323019
1
510(k) clearances
3,884
Adverse events (7 deaths)
4
Recalls
49
Facilities
Description
All Poly Patella
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-06-07 | Wright Medical Technology Inc | The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization m |
| 2009-05-14 | Wright Medical Technology Inc | Incorrect packaging, swapped sizes |
| 2009-05-14 | Wright Medical Technology Inc | Incorrect packaging, swapped sizes |
| 2004-01-09 | Stryker Howmedica Osteonics | This device is not approved for sale in the US. |
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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.