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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 Device Recall Proven Cemented Semi Constrained Total Knee see related information
Date Initiated by Firm September 03, 2008
Date Posted November 25, 2008
Recall Status1 Terminated 3 on December 04, 2008
Recall Number Z-0308-2009
Recall Event ID 49564
510(K)Number K980276  
Product Classification Knee patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. - 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 PA 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		 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 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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = STELKAST COMPANY
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