Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iNSitu Bipolar Hip System Recalled by Theken Companies LLC Due to Downstream recall for RES 97605, BioPro femoral components....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Theken Companies LLC directly.
Affected Products
iNSitu 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 Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm
Quantity: 409
Why Was This Recalled?
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Theken Companies LLC
Theken Companies LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report