Z-1782-2008

BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of...

Name: Z-1782-2008 BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of...
Creator: Biomet Sports Medicine
Published: 2008-04-17
License: https://open.fda.gov/license/

Biomet Sports Medicine / initiated 2008-04-17 / Terminated / root cause: manufacturing process

FDA source

Biomet Sports Medicine began a recall of BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic... on 2008-04-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1782-2008
Status: Terminated
Initiated: 2008-04-17
Posted: 2008-09-04
Terminated: 2012-01-13
Recalling firm: Biomet Sports Medicine
Product: BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 80
Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of Argentina, Chile, Italy, Netherlands, Norway & Poland.
Product codes and lots: Lot Number 305240

Product code MBI

K041261Class IIFemoral HookArthrotek, Inc. / cleared 2004-06-07

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)