FDA Device recall Z-0378-2017
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236 by Stryker Howmedica Osteonics, citing stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral He….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0378-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-29 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Reason
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Identifiers
| code_info | Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #626…Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0378-2017%22
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