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.
What this means for you
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.
- 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
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.
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