Bipolar hip heads recalled downstream after femoral components failed transit testing
Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.
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: Scored 3 under the risk-of-harm criterion: a potentially compromised sterile barrier on an implant creates an infection risk, and no injuries are reported.
Plain-English summary
The iNSitu Bipolar Hip System bipolar head implant is being recalled, covering part IDs 10-22-0038 (38mm), 10-22-0040 (40mm), 10-22-0042 (42mm) and 10-22-0044 (44mm).
This is a downstream recall tied to the BioPro femoral components action. The product failed transit testing, and impacted product may have potential issues with the sterile barrier.
The recall covers 409 units, with lots including 2036, 2036-RP, 3495 and 3495-1 for the 38mm head. The product was distributed in New Jersey, Pennsylvania and Texas. The FDA has classified the action as Class II.
The enforcement record describes the sterile barrier risk and reports no injuries. Facilities should quarantine affected lots and follow the firm's instructions.
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
- Hazard
- sterile-barrier-breach
- transit-testing-failure
- downstream-recall
- implant
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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