Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be us
FDA device recall Z-1871-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- Reason for recall
- The working tips of the Stella Osteotomes are thicker than specification.
- Action taken
- 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
- Status
- Terminated
- Product code
- EMM
- Quantity affected
- 36
- Distribution
- Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.
- Date initiated
- 2008-04-16
- Date posted
- 2008-09-11
- Date terminated
- 2009-09-11
- Location
- Jacksonville, FL
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