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U.S. Department of Health and Human Services

Class 2 Device Recall Proven Porous CR Femur

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  Class 2 Device Recall Proven Porous CR Femur see related information
Date Initiated by Firm September 24, 2004
Date Posted February 03, 2005
Recall Status1 Terminated 3 on February 07, 2005
Recall Number Z-0496-05
Recall Event ID 30287
510(K)Number K002281  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Proven Porous CR Femur. Implantable orthopedic device
Code Information Catalog number SC2113-2 Lot number 3763-012501, Catalog number SC2113-3 Lot number 3764-012501, Catalog number SC2113-4 Lot number 3765-012501, Catalog number SC2113-1 Lot number 3762-012501, Catalog number SC2113-6 Lot number 3767-012501, Catalog number SC2113-5 Lot number 3766-012501, Catalog number SC2114-4 Lot number 3771-012501, Catalog number SC2114-3 Lot number 3770-012501, Catalog number SC2114-1 Lot number 3768-012501, Catalog number SC2114-2 Lot number 3769-012501, Catalog number SC2114-6 Lot number 3773-012501, and Catalog number SC2114-5 Lot number 3772-012501.
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
Manufacturer Reason
for Recall		 Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
FDA Determined
Cause 2		 Other
Action The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
Quantity in Commerce 105 units
Distribution The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
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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