Agency classClass IIOur severity:High FDA (Devices)·Z-2486-2012·Announced 2012-10-10

Biomet Recalls OptiLock T15 AO Drivers Due to Fit Issues

Biomet, Inc. is recalling 363 units of OptiLock T15 AO Drivers because they may not properly lock into specified screw heads.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a design defect that may lead to improper fit and potential harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet, Inc. is recalling 363 units of the Optilock T15 AO Driver (3.5mm), catalog number 36505. The recall covers specific lot numbers including 069540, 179190, 201610, 385380, 419940, 427530, 440360, 440370, 555370, 638560, 645820, and 956960. The affected drivers were distributed nationwide in the United States and in Japan, the Netherlands, Australia, and Costa Rica.

The recall was initiated due to field complaints indicating that recent shipments of the drivers do not properly mate, or lock, into some of the specified screw heads. The issue occurs when drivers are near Maximum Material Condition (MMC) or are misshapen, which can prevent proper mating with screws at MMC. The design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screws.

The OptiLock Upper Extremity Plating System is intended for the fixation of fractures and osteotomies in the proximal humerus, olecranon, humerus, radius, and ulna, particularly in osteopenic bone. Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product: Optilock T15 AO Driver (3.5mm). 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…
Manufacturer: Biomet, Inc.
Category: Medical Device — Orthopedic Instrument
Hazard: improper-fit
design-defect
Affected units: 363

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

Catalog number: 36505
and lot numbers: 069540
179190
201610
385380
419940
427530
440360
440370
555370
638560
645820
and 956960.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Biomet, Inc.

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Same hazard · improper fit