Recall Z-1686-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of suf
| Date | Aug 21, 2009 (initiated May 7, 2009) |
| Status | Terminated |
| Reason | There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant. |
| Root cause | Process control |
| Action | The firm's sales staff was notified by email on May 7, 2009, and the recall was expanded to include additional lots on May 29, 2009, instructing them to remove the affected lots from their inventory and the inventory of any consignees, to provide the consignees with a copy of the recall letter, and to return the product to the firm. Hospital consignees were notified by letter dated May 7, 2009, as well as by updated letter on May 29, 2009. A dear doctor letter dated May 29, 2009 was issued to implanting surgeons advising them of the issue. Direct questions to Depuy Customer Service by calli |
| Quantity | 260 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943462 | DARWIN KNEE SYSTEM Johnson & Johnson Professionals, Inc., Dec 21, 1994 |