Recall Z-2136-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stelkast Co
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
| Date | Sep 3, 2013 (initiated Jun 24, 2013) |
| Status | Terminated |
| Reason | The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. |
| Root cause | Process control |
| Action | Stelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368. |
| Quantity | 11 |
| Distribution | Nationwide Distribution including TX, VA, OK, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021908 | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL Stelkast Company, Jul 9, 2002 |