LFIT Anatomic CoCr Femoral Heads — Class II medical device recall Z-2295-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-07-11, distributed nationwide. The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem
| Recall number | Z-2295-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2018-05-22 |
| Classified | 2018-07-02 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, CL, CN, DE, ES, FR, GB, IN, IT, JP, MY, NL, NZ, PL, PT, RO, SE, SG, ZA |
| Lot numbers | 000MPA, 13461301, 13461302, 14097201, 14097202, 14390101, 14390102, 14814301, 14934401, 14941101, 14973401, 15029001, 15029002, 15186801, 15186802, 15186803, 15341401, 15341402, 15341403, 15341404, 15629401, 15629402, 15759601, 16462601, 16551101, 16551102, 16575601, 16575602, 16644801, 16666901, 16684501, 17159001, 17159002, 17230201, 17230202, 18077901, 18110901, 18110902, 18110903, 18216001 and 310 more |
| Model numbers | 6260-9-136 |
Product
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Reason for recall
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2295-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.