Recall Z-0842-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-0842-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2022-01-14. It names one FDA 510(k) clearance: K052718. Product: Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032. Reason: Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-14
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K052718 — V40 BIOLOX DELTA CERAMIC FEMORAL HEADSHowmedica Osteonics Corp.·cleared 2005-10-27

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

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Reason for recall

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

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