Z-0378-2017 Class II Terminated
FDA device recall Z-0378-2017 was initiated by Stryker Howmedica Osteonics Corp. on August 29, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 2, 2017). Affected quantity: 42,519 units (total Catalog numbers).
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- August 29, 2016
- Termination Date
- May 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,519 units (total Catalog numbers)
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide and Internationally
Code Information
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.