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.
FDA Recall Z-0378-2017 · Posted None
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2016-08-29
Date Terminated2017-05-02
Product Quantity42,519 units (total Catalog numbers)
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.
Firm Action
Stryker notified their Branches/Agencies of this recall by e-mail on August 29, 2016 and they were asked to quarantine the affected devices. A Recall Notification Letter and Product Accountability Form was also sent on August 29, 2016 via UPS (with return receipt) to their Branches/Agencies/Hospital Risk Management and Surgeons. On October 11, 2016, Stryker sent an updated recall notification via UPS with return receipt to their affected customers because additional customers and lot numbers were identified.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide and Internationally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.