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U.S. Department of Health and Human Services

Class 3 Device Recall BIOMET MICROFIXATION

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  Class 3 Device Recall BIOMET MICROFIXATION see related information
Date Initiated by Firm October 05, 2009
Date Posted June 30, 2010
Recall Status1 Terminated 3 on December 15, 2010
Recall Number Z-1943-2010
Recall Event ID 54366
510(K)Number K953385  
Product Classification screw - Product Code JEY
Product BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.

Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
Code Information Lot 829760
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-4400
Manufacturer Reason
for Recall
Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
FDA Determined
Cause 2
Process design
Action Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.
Quantity in Commerce 91 units
Distribution US distribution: CA, CO, MI, and MO.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.
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