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U.S. Department of Health and Human Services

Class 2 Device Recall Latex Free Rubber Band

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  Class 2 Device Recall Latex Free Rubber Band see related information
Date Initiated by Firm August 18, 2011
Date Posted October 05, 2011
Recall Status1 Terminated 3 on February 06, 2012
Recall Number Z-0012-2012
Recall Event ID 59943
Product Classification Orthodontic elastic band - Product Code ECI
Product Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***."

Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***"

Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.


Code Information Model # SP-2411, lot 307850
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-9468
Manufacturer Reason
for Recall		 On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies.
FDA Determined
Cause 2		 Error in labeling
Action Biomet Microfixation, Jacksonville, FL sent a Urgent Medical Device letter dated August 19, 2011, to all affected customers. They were also notified by phone, and followed-up by e-mails starting on 08/18/2011. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed If you have any of the affected products in your facility, please remove it and return it immediately to Biomet Microfixation for credit. In order to return these products, please utilize the Return Goods Authorization (RGA) number provided on the reconciliation form. Please follow the instructions on the form and fill out the attached Inventory Reconciliation sheet and FAX to (904) 741-9425. If you have any further questions, please call 1-800-874-7711 or (904) -741-4400, extension 9468, Monday through Friday, 8am-4pm ET.
Quantity in Commerce 22 packs
Distribution Worldwide Distribution-- USA (nationwide) including the states of FL, KY, MN, NJ, SD, and VA., and the country of Australia.
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.
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