Recall Z-0977-04 ยท FTN Plastic Surgery And Accessories Kit
Mentor Texas, Inc
Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
| Date | Jul 20, 2004 (initiated Dec 16, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.