Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly when involving structural or design defects in medical devices that could lead to significant injury.
Plain-English summary
Exactech, Inc. is recalling 317 units of the Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53. The devices are sterile and require a prescription. The recall covers all lot numbers of this specific product configuration.
The recall is due to a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with the offset tibial tray. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
Distribution of the affected devices was made to Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. Foreign distribution included Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. Healthcare providers should contact Exactech for further instructions on handling the recalled devices.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 317
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 (1)
- All lot numbers
Distribution
Part of a larger recall action
This product is one of 34 recalled by Exactech, 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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