RecallDepth

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

This recall has been terminated (originally issued July 20, 2004).

Company
Mentor Texas, Inc
Recall Initiated
December 16, 2003
Posted
July 20, 2004
Terminated
May 25, 2004
Recall Number
Z-0977-04
Quantity
51 units
Firm Location
Irving, TX
Official Source
View on FDA website ↗

Reason for Recall

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

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 / Code Info

Lot numbers 269402 and 264358

Root Cause

Other

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.

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