Recall Z-0650-2016
Biomet, Inc. · initiated November 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Codes / lots: 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
Reason for recall
PMMA is listed as a material on the label but the product does not contain PMMA.
FDA-determined cause: Labeling Change Control
Action taken
On 11/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-0650-2016
- Initiated
- November 17, 2015
- Posted by FDA
- January 13, 2016
- Terminated
- July 5, 2016
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 21
- Distribution
- Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
- Recalling firm
- Biomet, Inc., Warsaw, IN