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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 MICROFIXATIONsee related information
Date Initiated by FirmOctober 05, 2009
Date PostedJune 30, 2010
Recall Status1 Terminated 3 on December 15, 2010
Recall NumberZ-1943-2010
Recall Event ID 54366
510(K)NumberK953385 
Product Classification screw - Product Code JEY
ProductBIOMET 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 ContactChristy 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
ActionBiomet 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 Commerce91 units
DistributionUS distribution: CA, CO, MI, and MO.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JEY
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