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Terminated

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).

FDA Recall Z-1871-2008 · Posted 2008-09-11

Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeEMM
Date Initiated2008-04-16
Date Terminated2009-09-11
Product Quantity36

Reason for Recall

The working tips of the Stella Osteotomes are thicker than specification.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.

Official Source

View FDA Recall →

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

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