[pending] iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Asse
Pending LLM rewrite. Source: FDA_DEVICE Z-0227-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
The recalled product
- Product
- 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 Asse
- Manufacturer
- Theken Companies LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 10-22-0038 UDI-DI 00816127029431 Lots 2036
- 2036-RP
- 3495
- 3495-1
- 10-22-0040 UDI-DI 00816127029448 Lots 2037
- 2037-RP
- 3491
- 3491-1
- 10-22-0042 UDI-DI 00816127029455 Lot 2038-RP
- 10-22-0044 UDI-DI 00816127029462 Lots 2039-RP
- 3496-1
- 10-22-0046 UDI-DI 00816127029479 Lots 2040
- 2040-RP
- 3492
- 3492-1
- 10-22-0048 UDI-DI 00816127029486 Lot 2041-RP
- 10-22-0050 UDI-DI 00816127029493 Lots 2042
- 2042-RP
- 10-22-0052 UDI-DI 00816127029509 Lots 2043
- 2043-RP
Distribution
Distributed nationwide across the United States.
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