Z-0650-2016 Class II Terminated
FDA device recall Z-0650-2016 was initiated by Biomet, Inc. on Nov 17, 2015 and is designated Class II. Reason for recall: PMMA is listed as a material on the label but the product does not contain PMMA. The recall status is terminated (terminated Jul 5, 2016). Affected quantity: 21.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Nov 17, 2015
- Termination Date
- Jul 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
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.
Distribution Pattern
Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
Code Information
Part #11-162709 9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0650-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026