Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech is recalling 573 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
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 is classified as FDA Class II, which indicates a risk of temporary or medically reversible adverse health consequences. The source text describes a design incompatibility but does not report specific injuries or illnesses, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 573 units of the Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42. The devices are sterile and require a prescription. The recall covers all lot numbers.
The recall is being conducted because of 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 or exposure to the product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed 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 how to handle the recalled devices.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 573
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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