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 sufficient sound bone to seat and support the components.
Recall
- Recall Number
- Z-1686-2009
- Event Number
- 52088
- Firm
- Depuy Orthopaedics, Inc.
- FEI Number
- 1818910
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 7, 2009
- Posted
- August 21, 2009
- Terminated
- October 25, 2010
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994
Description
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 sufficient sound bone to seat and support the components.
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.
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 calling 1-800-366-8143.
Nationwide.
260