Recall Z-1181-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012.
| Date | Aug 12, 2005 (initiated May 26, 2005) |
| Status | Terminated |
| Reason | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| Root cause | Other |
| Quantity | 18 |
| Distribution | Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033272 | DEPUY SIGMA TIBIAL INSERTS DePuy Orthopaedics, Inc., Feb 5, 2004 |