Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech is recalling 683 Optetrak Offset Tibial Tray and Screws units 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, and the source text describes a design incompatibility in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Exactech, Inc. is recalling 683 units of the Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33. The recall involves all lot numbers of this sterile, prescription medical device.
The recall was initiated 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, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 stop using the affected devices and contact Exactech for further instructions.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 683
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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