Recall Z-0650-2016 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Biomet, Inc.
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
| Date | Jan 13, 2016 (initiated Nov 17, 2015) |
| Status | Terminated |
| Reason | PMMA is listed as a material on the label but the product does not contain PMMA. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 21 |
| Distribution | Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942479 | INTEGRAL CO-CR FEMORAL COMPONENT Biomet, Inc., Sep 20, 1994 |