Z-0278-2008

Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover...

Name: Z-0278-2008 Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover...
Creator: Straumann USA LLC
Published: 2007-09-28
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2007-09-28 / Terminated / root cause: design

FDA source

Straumann USA LLC began a recall of Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 on 2007-09-28. The reason FDA records is "Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0278-2008
Status: Terminated
Initiated: 2007-09-28
Posted: 2007-12-04
Terminated: 2010-04-16
Recalling firm: Straumann USA, LLC
Product: Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
Product code: OAT Implant, Endosseous, Orthodontic
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 32 units
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.
Product codes and lots: Lot Number: 1001

Product code OAT

K060062Class IIStraumann OrthosystemInstitut Straumann AG / cleared 2006-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)