Recall Z-1449-2012 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Biomet, Inc.
Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement
| Date | Apr 23, 2012 (initiated Sep 13, 2011) |
| Status | Terminated |
| Reason | Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet contacted consignees with device inventory by telephone on September 13, 2011 requesting all associated product be quarantined immediately. An Urgent Medical Device Recall Notice was sent via U.S. mail March 23, 2012 to consignees with directions to immediately locate, discontinue use of the affected product and return to Biomet. The letter instructed consignees to carefully follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. The notification letter to consignees contained directions to confi |
| Quantity | 5 devices |
| Distribution | USA Nationwide Distribution including the states of: MI, NC., OK and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062997 | ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS Biomet Manufacturing Corp, Dec 8, 2006 |