FDA Medical Device Recalls (openFDA)
Depuy Mitek, a Johnson & Johnson Co.: Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
- Recall number
- Z-0610-06
- Recalling firm
- Depuy Mitek, a Johnson & Johnson Co.
- Product
- Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2006-03-15
- Terminated
- 2006-06-28
- Reason
- The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- Root cause
- Other
- Action
- Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
- Quantity
- 200 pieces
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: 1358481 Exp Date: Nov 2008
- 510(k) numbers
- ["K002639"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1221934
- Firm city
- Raynham
- 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