Z-2485-2012Class II

Optilock 2.7 mm Screw Inserter

Name: Z-2485-2012 Optilock 2.7 mm Screw Inserter
Creator: Biomet, Inc.
Published: 2012-08-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-08-23 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is... on 2012-08-23. FDA classified it as Class II and gives the reason as "Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2485-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-23
Posted: 2012-09-28
Terminated: 2013-08-27
Recalling firm: Zimmer GmbH
Product: Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Product code: HXX Screwdriver
Reason for recall: Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
Root cause tag: design
FDA root cause: Mixed-up of materials/components
Action: Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE'' dated August 23, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. A Fax Back Response Form was included for customers to complete and return via fax to 574-372-1683. Contact the firm at 574-372-1570 for questions related to this recall.
Quantity in commerce: 268 units total
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
Product codes and lots: Catalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2485-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2486-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

Product code HXX

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)