FDA Medical Device Recalls (openFDA)
Mentor Texas, Inc: Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
- Recall number
- Z-0977-04
- Recalling firm
- Mentor Texas, Inc
- Product
- Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
- Status
- Terminated
- Initiated
- 2003-12-16
- Posted
- 2004-07-20
- Terminated
- 2004-05-25
- Reason
- Device was distributed without the dome part accessory, part number 350-DOMPK
- Root cause
- Other
- Action
- The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.
- Quantity
- 51 units
- Distribution
- Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.
- Lot, serial or model codes
- Lot numbers 269402 and 264358
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTN
- Firm FEI
- 1000118360
- Firm city
- Irving
- Firm state
- TX
- 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