Home › PAXEON RECONSTRUCTION LLC › Paxeon BiPolar Head
Paxeon BiPolar Head
PAXEON RECONSTRUCTION LLC · Model PR111-21-2843 · UDI-DI 08177570201839
KWY
Prescription
1
510(k) clearances
16,502
Adverse events (49 deaths)
88
Recalls
214
Facilities
Description
Bipolar Head Size 28/43
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Total Joint Orthopedics, 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 |
| 2024-10-15 | Smith & Nephew, Inc. | The Bipolar assembly contains an oversized Retainer Ring. |
| 2024-04-26 | Exactech, Inc. | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packagin |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.