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Terminated

Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.

FDA Recall Z-0390-2010 · Posted 2009-11-23

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDG
Date Initiated2009-09-04
Date Terminated2013-06-26
Product Quantity7 units

Reason for Recall

Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.

Firm Action

Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.

Root Cause

Process control

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061434TRIDENT LARGE DIAMETER HIP SYSTEMHowmedica Osteonics Corp. · 2006-08-22K02207736MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)Howmedica Osteonics Corp. · 2002-07-25K010757LFIT V40 FEMORAL HEAD COMPONENTSHowmedica Osteonics Corp. · 2001-04-11K993601HOWMEDICA OSTEONICS FEMORAL HEADSHowmedica Osteonics Corp. · 1999-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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