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Restoration
Howmedica Osteonics Corp. · Model 6276-7-115 · UDI-DI 07613154058617
10
510(k) clearances
2,683
Adverse events (4 deaths)
50
Recalls
145
Facilities
Description
Modular Hip System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2018-06-21 | DePuy Orthopaedics, Inc. | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and addition |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH |
| 2015-11-16 | Smith & Nephew, Inc. | The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actua |
| 2009-06-26 | Stryker Howmedica Osteonics Corp. | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-complianc |
| 2009-01-06 | Stryker Howmedica Osteonics Corp. | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| 2007-10-26 | Stryker Howmedica Osteonics Corp. | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
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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.