FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1, BIOMET MICROFIXATION, INC., 150 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA Instrument used to pull up the broken bone, so it is flush and can be plated fixated. The Byrd screw is then removed.
- Recall number
- Z-0169-2010
- Recalling firm
- Biomet Microfixation, Inc.
- Product
- Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1, BIOMET MICROFIXATION, INC., 150 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA Instrument used to pull up the broken bone, so it is flush and can be plated fixated. The Byrd screw is then removed.
- Status
- Terminated
- Initiated
- 2009-02-19
- Posted
- 2009-11-10
- Terminated
- 2012-05-03
- Reason
- Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.
- Root cause
- Nonconforming Material/Component
- Action
- Biomet plans to send letters to customers on February 19, 2009. Customers are told to discontinue use of the item and return it to Biomet Microfixation. The firm plans to follow up with an e-mail to their customers. Questions pertaining to this issue, should be directed to Christy Cain at 1.800.874.7711 or 904.741.4400.
- Quantity
- 22
- Distribution
- AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada.
- Lot, serial or model codes
- Lot # 091807107
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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