Recall Z-1241-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1241-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-03

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-02-03, terminated 2017-04-07. It names one FDA 510(k) clearance: K010757. Product: LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.. Reason: Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Terminated: 2017-04-07
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K010757 — LFIT V40 FEMORAL HEAD COMPONENTSHowmedica Osteonics Corp.·cleared 2001-04-11

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

LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

Reason for recall

Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.

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