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.
FDA Recall Z-2136-2013 · Posted 2013-09-03
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Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeJWH
Date Initiated2013-06-24
Date Terminated2014-10-08
Product Quantity11
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including TX, VA, OK, and PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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