Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven K
FDA device recall Z-0308-2009 · posted 2008-11-25 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 5 units
- Distribution
- Nationwide Distribution --- including states of IA and WV.
- Date initiated
- 2008-09-03
- Date posted
- 2008-11-25
- Date terminated
- 2008-12-04
- Location
- Mcmurray, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM (K980276) | Stelkast Company | 1998-04-24 |