Recall Z-1465-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
| Date | Jun 5, 2013 (initiated Apr 26, 2013) |
| Status | Terminated |
| Reason | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size. |
| Root cause | Labeling mix-ups |
| Action | Biomet sent an Urgent Medical Device Recall letter dated April 26, 2013 to consignees detailing that the outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. This action requires the immediate location and discontinued use of the product and its return to Biomet. Ciustomers were advised to: Immediately locate and remove the identified device(s) listed from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . - Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority ca |
| Quantity | 8 units |
| Distribution | Distributed in New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101336 | E1 AVANTAGE HEAD Biomet Manufacturing Corp, Jan 14, 2011 |