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U.S. Department of Health and Human Services

Class 2 Device Recall 2.0/1.0 4 hole long plate Model 019205

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  Class 2 Device Recall 2.0/1.0 4 hole long plate Model 019205 see related information
Date Initiated by Firm August 31, 2010
Date Posted October 20, 2010
Recall Status1 Terminated 3 on November 19, 2010
Recall Number Z-0108-2011
Recall Event ID 56802
510(K)Number K854886  
Product Classification Plate, bone - Product Code JEY
Product 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150.
Product labeling reads:
(1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG.
(2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com.
(3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086
Code Information Lot 120150.
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Laura Sabo
904-741-4400
Manufacturer Reason
for Recall		 Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).
FDA Determined
Cause 2		 Other
Action Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.
Quantity in Commerce 56
Distribution Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.
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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