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U.S. Department of Health and Human Services

Class 2 Device Recall Byrd Screw

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 Class 2 Recall
Byrd Screw
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on May 03, 2012
Recall Number Z-0169-2010
Recall Event ID 52639
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Lot # 091807107
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Laura Sabo
904-741-4400 Ext. 482
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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