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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 22, 2004
Date Posted December 01, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-0241-06
Recall Event ID 31985
510(K)Number K034002  
Product Classification Nail, Fixation, Bone, Metallic - Product Code NDH
Product Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
Code Information Catalog 3220-0320S Lot K949408  3225-0360S, lot code K949396
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
FDA Determined
Cause 2		 Other
Action Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
Quantity in Commerce 19
Distribution The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
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 = NDH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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