Recall Z-1004-2009 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Smith & Nephew Inc
Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
| Date | Apr 21, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | Liners measuring 28 mm ID and were mismarked as 32 mm. |
| Root cause | Process control |
| Action | All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441. |
| Quantity | 19 units |
| Distribution | International Distribution to Canada, France, Germany and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991026 | REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc., Oct 22, 1999 |