Recall Z-2296-2018— Howmedica Osteonics Corp.

Name: FDA recall Z-2296-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-22

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2018-05-22, terminated 2020-05-08. It names one FDA 510(k) clearance: K022077. Product: LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140. Reason: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-05-22
Terminated: 2020-05-08
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 CoCr Femoral Heads, Catalog No. 6260-9-140

Reason for recall

The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.

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