Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
FDA device recall Z-0977-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Mentor Texas, Inc
- Reason for recall
- Device was distributed without the dome part accessory, part number 350-DOMPK
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTN
- Quantity affected
- 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.
- Date initiated
- 2003-12-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-25
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.