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U.S. Department of Health and Human Services

Class 2 Device Recall Stainless Steel Surgical Blades

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 Class 2 Recall
Stainless Steel Surgical Blades
see related information
Date Posted February 20, 2009
Recall Status1 Terminated on February 23, 2009
Recall Number Z-0862-2009
Recall Event ID 50499
Premarket Notification
510(K) Number
K022549 
Product Classification Blade, Scalpel - Product Code GES
Product Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
Code Information Lot number S07C06
Recalling Firm/
Manufacturer
Miltex, Inc.
589 Davies Drive
York, Pennsylvania 17402
For Additional Information Contact Patricia Kihn
717-840-3431
Manufacturer Reason
for Recall
Blade may break: Over milling of the blade resulted in tip more narrow than specified.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action An Urgent Medical Device Recall letter dated 11/17/08 with an accompanying fax back form was sent to each customer. Each distributor was instructed to review their inventory, complete the form, and return any affected product. The distributors were also instructed to conduct a sub recall notification.
Quantity in Commerce 200 boxes
Distribution Nationwide Distribution and Canada.
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 = GES and Original Applicant = HOWMEDICA OSTEONICS CORP.
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