FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
- Recall number
- Z-0538-2010
- Recalling firm
- Biomet Microfixation, Inc.
- Product
- Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2009-12-16
- Terminated
- 2010-03-02
- Reason
- The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).
- Root cause
- Process change control
- Action
- Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.
- Quantity
- 283 pieces
- Distribution
- Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.
- Lot, serial or model codes
- Lots: 535933, 536306 and 537407.
- 510(k) numbers
- ["K062842"]
- PMA numbers
- not on file
- Product code
- HBE
- 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