Z-1871-2008

Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is...

Name: Z-1871-2008 Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is...
Creator: Biomet Microfixation, Inc.
Published: 2008-04-16
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2008-04-16 / Terminated / root cause: manufacturing process

FDA source

Biomet Microfixation, Inc. began a recall of Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy... on 2008-04-16. The reason FDA records is "The working tips of the Stella Osteotomes are thicker than specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1871-2008
Status: Terminated
Initiated: 2008-04-16
Posted: 2008-09-11
Terminated: 2009-09-11
Recalling firm: Biomet Microfixation
Product: Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).
Product code: EMM Chisel, Osteotome, Surgical
Reason for recall: The working tips of the Stella Osteotomes are thicker than specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified its consignees on 4/16/08 by certified mail with return receipt. Sub-accounts were contacted by email. All returned product will be stored in quarantine until a final determination of disposition is made.
Quantity in commerce: 36
Distribution: Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.
Product codes and lots: Lot numbers: 381250, 381251, 439970, 381240, 356510,513250 and 354320.

Product code EMM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)