BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated for use for fixation of tendons &

FDA device recall Z-1783-2008 · posted 2008-09-04 · Terminated

Recall details

Recalling firm

Biomet Sports Medicine

Reason for recall

This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1

Action taken

An Urgent Medical Device Removal Notice was issued by BIOMET on May 2, 2008, to all customers in the United States via overnight carrier (UPS). The U.S. Removal Notice was used as a template for all global communications regarding this urgent removal notice. Included in this recall correspondence were three Recall Letters; one for direct customers, one for Physicians and one for distributors. The notice informed customers of the problem and the risks associated with the use of this product (note: The Physician letter included more detail instruction for physician with patients already implanted with the devices). The customers were instructed to take the following actions: (1) Immediately locate, discontinue use , and quarantine the implants referenced. (2) Return the product listed in table below to Biomet Sports Medicine at the address provided. (3) Include a copy of this letter with your returned products. (4) Use priority carrier for your shipment. (5) If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed Dear Biomet Customer notice. For questions related to this notice, an 800 number and contact person was referenced in the letter. The recalled product will be returned to the firm's warehouse and quarantined until final disposition is determined after notification to the local FDA office.

Root cause

Employee error

Status

Terminated

Product code

MBI

Quantity affected

80

Distribution

Class II Recall - Worldwide Distribution --- including USA and countries of Argentina, Chile, Italy, Netherlands, Norway & Poland.

Date initiated

2008-04-17

Date posted

2008-09-04

Date terminated

2012-01-13

Location

Ontario, CA

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