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Class 2 Device Recall Center Drive Stainless Steel 2.0MM System Screwdriver Blade |
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Date Initiated by Firm |
March 15, 2010 |
Date Posted |
August 01, 2011 |
Recall Status1 |
Terminated 3 on November 09, 2011 |
Recall Number |
Z-2913-2011 |
Recall Event ID |
58920 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product |
"***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***"
Blade used to implant screws. |
Code Information |
Lot 064980 |
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
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Manufacturer Reason for Recall |
Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws).
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm, Biomet Microfixation, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed.
If you have any questions, contact the Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET. |
Quantity in Commerce |
35 |
Distribution |
Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa. |
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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