Exactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility
Exactech, Inc. is recalling 640 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, which typically involves a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a design incompatibility in a medical device where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Exactech, Inc. is recalling 640 units of Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX. The recall involves all lot numbers of this specific product configuration.
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 incompatibility could potentially affect the stability or function of the knee implant system during surgical use.
The affected devices were distributed to hospitals and medical facilities in 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, Inc. for instructions on how to return the devices and obtain replacements.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 640
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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