Z-2913-2011

"BIOMET MICROFIXATIONCENTER DRIVE STAINLESS STEEL2.0MM SYSTEM SCREWDRIVER BLADENon-Sterile...

Name: Z-2913-2011 "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile...
Creator: Biomet Microfixation, Inc.
Published: 2010-03-15
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-03-15 / Terminated / root cause: manufacturing process

FDA source

Biomet Microfixation, Inc. began a recall of "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE... on 2010-03-15. The reason FDA records is "Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws)". 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-2913-2011
Status: Terminated
Initiated: 2010-03-15
Posted: 2011-08-01
Terminated: 2011-11-09
Recalling firm: Biomet Microfixation
Product: "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Blade used to implant screws.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Biomet Microfixation, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed. If you have any questions, contact the Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Quantity in commerce: 35
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa.
Product codes and lots: Lot 064980

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)