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Terminated

Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008

FDA Recall Z-0277-2008 · Posted 2007-12-04

Recalling FirmStraumann USA LLC
Recall StatusTerminated
Product CodeOAT
Date Initiated2007-09-28
Date Terminated2010-04-16
Product Quantity58 units

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060062STRAUMANN ORTHOSYSTEMInstitut Straumann AG · 2006-02-03

Official Source

View FDA Recall →

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

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