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Pantheon PFR System
ADLER ORTHO SPA · Model Compression Screw · UDI-DI 08050880237968
10
510(k) clearances
89,776
Adverse events (195 deaths)
297
Recalls
265
Facilities
Description
Pantheon Salvage Plate with Spikes Compression Screw (Medium)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-05 | Encore Medical, LP | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discr |
| 2025-09-26 | Zimmer, Inc. | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, howe |
| 2025-09-26 | Zimmer, Inc. | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, howe |
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2025-06-12 | Encore Medical, LP | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. |
| 2025-06-12 | Encore Medical, LP | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. |
| 2025-03-25 | Conformis Inc. | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner. |
| 2024-12-31 | Exactech, Inc. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-09-19 | Novosource, LLC | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted |
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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.