Recall Z-0261-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0261-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-08

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-09-08, terminated 2017-07-25. It names one FDA 510(k) clearance: K121308. Product: Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.. Reason: Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Terminated: 2017-07-25
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K121308 — HIP SYSTEMSHowmedica Osteonics Corp.·cleared 2012-07-30

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

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

Reason for recall

Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

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