Recall Z-2054-2011 ยท MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
| Date | Apr 22, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| Reason | During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners. |
| Root cause | Employee error |
| Action | All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions. |
| Quantity | 325 units |
| Distribution | AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.