Recall Z-0081-2011 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Smith & Nephew Inc
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular Liner
| Date | Oct 18, 2010 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | The firm received reports of a femoral head popping out of the liner intraoperatively. |
| Root cause | Other |
| Action | Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. 1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. 2) Identify customers that received these products and immediately notify them of the recall. 3) Carry out a physical count and record |
| Quantity | 89 units |
| Distribution | Worlwide Distribution, USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and WI and the countries of Australia and Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER Smith & Nephew, Inc., Mar 3, 2009 |