FDA Medical Device Recalls (openFDA)
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 number
- Z-1871-2008
- Recalling firm
- Biomet Microfixation, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2008-04-16
- Posted
- 2008-09-11
- Terminated
- 2009-09-11
- Reason
- The working tips of the Stella Osteotomes are thicker than specification.
- 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
- 36
- Distribution
- Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.
- Lot, serial or model codes
- Lot numbers: 381250, 381251, 439970, 381240, 356510,513250 and 354320.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EMM
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28