Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containin
FDA device recall Z-0862-2009 · posted 2009-02-20 · Terminated
Recall details
- Recalling firm
- Miltex, Inc.
- Reason for recall
- Blade may break: Over milling of the blade resulted in tip more narrow than specified.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GES
- Quantity affected
- 200 boxes
- Distribution
- Nationwide Distribution and Canada.
- Date initiated
- 2008-11-17
- Date posted
- 2009-02-20
- Date terminated
- 2009-02-23
- Location
- York, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.