iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-
Summary
The FDA issued a Class II for iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-00 by Theken Companies LLC. Reason: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile ba.
Details
Source
Device Recall
External ID
Z-0227-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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; 10-22-0054 UDI-DI 00816127029516 Lots 2044, 2044-RP; 10-22-0056 UDI-DI 00816127029523 Lots 2045, 2045-RP; 10-22-0058 UDI-DI 00816127029530 Lots 2046, 2046-RP, 3493; 10-22-0060 UDI-DI 00816127029547 Lots 2047, 2047-RP, 3494 All lots/serial numbers
Quantity Affected: 409
Reason for Recall
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Distribution
US Nationwide distribution in the states of NJ, PA, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-11
Company
Akron, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Theken Companies LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Theken Companies LLC have FDA actions?
This is the only FDA action we have on record for Theken Companies LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0227-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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