Z-0012-2012

Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY...

Name: Z-0012-2012 Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY...
Creator: Biomet Microfixation, Inc.
Published: 2011-08-18
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2011-08-18 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, Inc. began a recall of 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... on 2011-08-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0012-2012
Status: Terminated
Initiated: 2011-08-18
Posted: 2011-10-05
Terminated: 2012-02-06
Recalling firm: Biomet Microfixation
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.
Product code: ECI Band, Elastic, Orthodontic
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model # SP-2411, lot 307850

Product code ECI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)