Theken Companies LLC recalls iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0…

Recall date

September 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0227-2026

FDA classification

Class II

Brand / firm

Theken Companies LLC

Sold / distributed

US Nationwide distribution in the states of NJ, PA, and TX.

Why it was recalled

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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