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Class 2 Device Recall Byrd Screw |
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Date Initiated by Firm |
February 19, 2009 |
Date Posted |
November 10, 2009 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number |
Z-0169-2010 |
Recall Event ID |
52639 |
Product Classification |
Screw - Product Code LXH
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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.
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Code Information |
Lot # 091807107 |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
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For Additional Information Contact |
Laura Sabo 904-741-4400 Ext. 482
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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