Z-2206-2010

BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF...

Name: Z-2206-2010 BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF...
Creator: Biomet Microfixation, Inc.
Published: 2010-03-17
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-03-17 / Terminated

FDA source

Biomet Microfixation, Inc. began a recall of BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET... on 2010-03-17. The reason FDA records is "Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2206-2010
Status: Terminated
Initiated: 2010-03-17
Posted: 2010-08-11
Terminated: 2010-08-11
Recalling firm: Biomet Microfixation
Product: BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Product code: DZL Screw, Fixation, Intraosseous
Reason for recall: Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
FDA root cause: Other
Action: Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.
Quantity in commerce: 1247 screws
Distribution: Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.
Product codes and lots: Lot 148530

Product code DZL

K953385Class IILorenz 1.0Mm, 1.5Mm, 2.0Mm SystemWalter Lorenz Surgical, Inc. / cleared 1995-09-28

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)