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Terminated

Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas

FDA Recall Z-0977-04 · Posted 2004-07-20

Recalling FirmMentor Texas, Inc
Recall StatusTerminated
Product CodeFTN
Date Initiated2003-12-16
Date Terminated2004-05-25
Product Quantity51 units

Reason for Recall

Device was distributed without the dome part accessory, part number 350-DOMPK

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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