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).
This recall has been terminated (originally issued September 11, 2008).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- April 16, 2008
- Posted
- September 11, 2008
- Terminated
- September 11, 2009
- Recall Number
- Z-1871-2008
- Quantity
- 36
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The working tips of the Stella Osteotomes are thicker than specification.
Distribution
Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.
Lot / Code Info
Lot numbers: 381250, 381251, 439970, 381240, 356510,513250 and 354320.
Root Cause
Nonconforming Material/Component
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.
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