Recall Z-2136-2013
Stelkast Co · initiated June 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2136-2013
- Initiated
- June 24, 2013
- Posted by FDA
- September 3, 2013
- Terminated
- October 8, 2014
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 11
- Distribution
- Nationwide Distribution including TX, VA, OK, and PA
- Recalling firm
- Stelkast Co, Mcmurray, PA