Z-0169-2010

Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264...

Name: Z-0169-2010 Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264...
Creator: Biomet Microfixation, Inc.
Published: 2009-02-19
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2009-02-19 / Terminated / root cause: manufacturing process

FDA source

Biomet Microfixation, Inc. began a recall of 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... on 2009-02-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0169-2010
Status: Terminated
Initiated: 2009-02-19
Posted: 2009-11-10
Terminated: 2012-05-03
Recalling firm: Biomet Microfixation
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 22
Distribution: AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada.
Product codes and lots: Lot # 091807107

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)