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Theken Companies LLC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Theken Companies LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-29FDA-DeviceClass IIiNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
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