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PHYSICA MIS
LIMACORPORATE SPA · Model Femoral Sizing Stylus · UDI-DI 08033390133678
1
510(k) clearances
9,644
Adverse events (9 deaths)
68
Recalls
122
Facilities
Description
Femoral A/P Sizing Stylus
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-03 | MicroPort Orthopedics Inc. | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN |
| 2022-12-15 | Biomet, Inc. | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in t |
| 2022-10-28 | MicroPort Orthopedics Inc. | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution |
| 2022-10-28 | MicroPort Orthopedics Inc. | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution |
| 2021-08-30 | Exactech, Inc. | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 | Aesculap Implant Systems LLC | Malfunction- loosening of the implant resulting in a potential revision surgery |
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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.