Date Initiated by Firm |
November 17, 2008 |
Date Posted |
February 20, 2009 |
Recall Status1 |
Terminated 3 on February 23, 2009 |
Recall Number |
Z-0862-2009 |
Recall Event ID |
50499 |
Product Classification |
surgical 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 PA 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 |
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
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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.
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