PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 20, 2016 Initiated: November 17, 2015 #Z-0650-2016

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
21
Distribution
Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm. Recalled by Biomet, Inc.. Units affected: 21.
Why was this product recalled?
PMMA is listed as a material on the label but the product does not contain PMMA.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0650-2016.