SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthri
FDA device recall Z-2136-2013 · posted 2013-09-03 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 11
- Distribution
- Nationwide Distribution including TX, VA, OK, and PA
- Date initiated
- 2013-06-24
- Date posted
- 2013-09-03
- Date terminated
- 2014-10-08
- Location
- Mcmurray, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROVEN MODULAR POSTERIOR STABILIZED FEMORAL (K021908) | Stelkast Company | 2002-07-09 |