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APEX Knee System
Omni Life Science, Inc. · Model XK-00063 · UDI-DI 00841690183754
9
510(k) clearances
285
Adverse events (1 deaths)
2
Recalls
265
Facilities
Description
EVO Punch Dart w additional cement mantle sz 1-2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
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