FDA Medical Device Recalls (openFDA)
Miltex, Inc.: Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
- Recall number
- Z-0862-2009
- Recalling firm
- Miltex, Inc.
- Product
- Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
- Status
- Terminated
- Initiated
- 2008-11-17
- Posted
- 2009-02-20
- Terminated
- 2009-02-23
- Reason
- Blade may break: Over milling of the blade resulted in tip more narrow than specified.
- Root cause
- 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
- 200 boxes
- Distribution
- Nationwide Distribution and Canada.
- Lot, serial or model codes
- Lot number S07C06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GES
- Firm FEI
- 2518040
- Firm city
- York
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28