Straumann USA LLC Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
Brand
Straumann USA LLC
Lot Codes / Batch Numbers
Lot Numbers: 1001, F3776, F4662, F6563, E7083
Products Sold
Lot Numbers: 1001, F3776, F4662, F6563, E7083
Straumann USA LLC is recalling Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, M due to Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026