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U.S. Department of Health and Human Services

Class 2 Device Recall Proven Cemented Semi Constrained Total Knee

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 Class 2 Recall
Proven Cemented Semi Constrained Total Knee
see related information
Date Posted November 25, 2008
Recall Status1 Terminated on December 04, 2008
Recall Number Z-0308-2009
Recall Event ID 49564
Premarket Notification
510(K) Number
K980276 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis.
Code Information Part number SC1591-38. Lot number 19906-052008
Recalling Firm/
Manufacturer
Stelkast Co
200 Hidden Valley Rd
Mcmurray, Pennsylvania 15317-2659
For Additional Information Contact John J. Litwin
724-731-2225
Manufacturer Reason
for Recall
Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
FDA Determined
Cause 2
TRAINING: Employee Error
Action 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.
Quantity in Commerce 5 units
Distribution Nationwide Distribution --- including states of IA and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = STELKAST COMPANY
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