Z-1943-2010

BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL)...

Name: Z-1943-2010 BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL)...
Creator: Biomet Microfixation, Inc.
Published: 2009-10-05
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2009-10-05 / Terminated / root cause: manufacturing process

FDA source

Biomet Microfixation, Inc. began a recall of BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone... on 2009-10-05. The reason FDA records is "Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw". 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-1943-2010
Status: Terminated
Initiated: 2009-10-05
Posted: 2010-06-30
Terminated: 2010-12-15
Recalling firm: Biomet Microfixation
Product: BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
Product code: JEY Plate, Bone
Reason for recall: Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.
Quantity in commerce: 91 units
Distribution: US distribution: CA, CO, MI, and MO.
Product codes and lots: Lot 829760

Product code JEY

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