Date Initiated by Firm | June 24, 2013 |
Date Posted | September 03, 2013 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number | Z-2136-2013 |
Recall Event ID |
65823 |
510(K)Number | K021908 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Stelkast Co 200 Hidden Valley Rd Mcmurray PA 15317-2659
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For Additional Information Contact | Stelkast Customer Service 724-941-6368 |
Manufacturer 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 2 | Process control |
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. |
Quantity in Commerce | 11 |
Distribution | Nationwide Distribution including TX, VA, OK, and PA |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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