Recall Z-0308-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stelkast Co
Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformiti
| Date | Nov 25, 2008 (initiated Sep 3, 2008) |
| Status | Terminated |
| Reason | Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number. |
| Root cause | Employee error |
| Action | On 9/4/08, the recalling firm telephoned their customers to inform them of the problem and asked them to immediately recover all SC1591-38 with lot number 19906-052008. Once the product is in their possession, customers should contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. |
| Quantity | 5 units |
| Distribution | Nationwide Distribution --- including states of IA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM Stelkast Company, Apr 24, 1998 |