Recall Z-0650-2016— Biomet, Inc.

Name: FDA recall Z-0650-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-17

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-11-17, terminated 2016-07-05. It names one FDA 510(k) clearance: K942479. Product: Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm. Reason: PMMA is listed as a material on the label but the product does not contain PMMA..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Terminated: 2016-07-05
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K942479 — INTEGRAL CO-CR FEMORAL COMPONENTBiomet, Inc.·cleared 1994-09-20

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

Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

Reason for recall

PMMA is listed as a material on the label but the product does not contain PMMA.

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