Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech is recalling 678 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain 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 typically 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 678 units of the Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX. 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 an offset tibial tray.
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. All lot numbers are affected.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers should stop using the affected devices and contact Exactech for further instructions.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 678
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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