Recall Z-0415-2013 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Biomet, Inc.
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individ
| Date | Nov 21, 2012 (initiated Oct 4, 2012) |
| Status | Terminated |
| Reason | The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) |
| Root cause | Labeling Change Control |
| Action | BIOMET called distributors who received the affected product to return it to Biomet with follow-up Urgent Recall Notices sent via E-mail October 22, 2012.. The notice included the identity of the recalled device, reason for the recall, and directions to complete the FAX back form and return it to 574-372-1683. Product is to be returned to Return Goods, Recalls, Biomet, Inc. 56 East Bell Drive, Warsaw, IN 46580. Questions related to the recall should be directed to Field Action Coordinator (574) 372-1570, Monday through Friday. 8 a.m. to 5 p.m. For questions regarding this recall call 574-267- |
| Quantity | 16 (5 USA) |
| Distribution | Nationwide Distribution including CA, IN, NC, OH, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050124 | POROUS COATED ACETABULAR COMPONENTS Biomet, Inc., Oct 4, 2005 |