Recall Z-0378-2017— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0378-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-29

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-08-29, terminated 2017-05-02. It names one FDA 510(k) clearance: K022077. 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Terminated: 2017-05-02
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K022077 — 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)Howmedica Osteonics Corp.·cleared 2002-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.