FDA Medical Device Recalls (openFDA)
Mitek Worldwide: Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325
- Recall number
- Z-1004-03
- Recalling firm
- Mitek Worldwide
- Product
- Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325
- Status
- Terminated
- Initiated
- 2003-06-16
- Posted
- 2003-07-15
- Terminated
- 2003-10-22
- Reason
- Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
- Root cause
- Other
- Action
- Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.
- Quantity
- 40
- Distribution
- CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain
- Lot, serial or model codes
- Lot Number: 0207145 Exp 2007-7
- 510(k) numbers
- ["K982662"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- not on file
- Firm city
- Norwood
- Firm state
- MA
- 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