Biomet Microfixation, Inc. 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Biomet Microfixation, Inc.
Lot Codes / Batch Numbers
Lot numbers: 381250, 381251, 439970, 381240, 356510, 513250 and 354320.
Products Sold
Lot numbers: 381250, 381251, 439970, 381240, 356510,513250 and 354320.
Biomet Microfixation, Inc. is recalling Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product due to The working tips of the Stella Osteotomes are thicker than specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The working tips of the Stella Osteotomes are thicker than specification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO, NM, TX
Page updated: Jan 10, 2026