Medical Device Recall: Z-0012-2012

FDA Recalls dataset · Firm: Biomet Microfixation, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-08-18 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2012.

Recall Res Number
Z-0012-2012
Recalling Firm / Manufacturer
Biomet Microfixation, Inc.
FEI Number
1032347
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-08-18
Date Posted
2011-10-05
Date Terminated
2012-02-06
Product Code
ECI
Event Number
59943
Product Quantity
22 packs
Product Description 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.
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.
Action Details 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.
Distribution Pattern Worldwide Distribution-- USA (nationwide) including the states of FL, KY, MN, NJ, SD, and VA., and the country of Australia.
Code Information / Serial Numbers Model # SP-2411, lot 307850

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