Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
- Company
- Straumann Usa Llc
- Recall Initiated
- September 28, 2007
- Posted
- December 4, 2007
- Terminated
- April 16, 2010
- Recall Number
- Z-0278-2008
- Quantity
- 32 units
- Firm Location
- Andover, MA
Reason for Recall
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
Distribution
Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
Lot / Code Info
Lot Number: 1001
Root Cause
Device Design
Action Taken
Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
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