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.
This recall has been terminated (originally issued November 10, 2009).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- February 19, 2009
- Posted
- November 10, 2009
- Terminated
- May 3, 2012
- Recall Number
- Z-0169-2010
- Quantity
- 22
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada.
Lot / Code Info
Lot # 091807107
Root Cause
Nonconforming Material/Component
Action Taken
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.