Recall Z-1145-05 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Depuy Orthopaedics, Inc.
Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 4, 7.0 mm; Ref 1498-11-406.
| 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 | 58 |
| 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
| K010810 | DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS DePuy Orthopaedics, Inc., Apr 18, 2001 |