Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 386 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
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 does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 386 units of the Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81. The devices are sterile and require a prescription. The recall covers all lot numbers of this specific product.
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. 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.
Distribution was made to Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. Healthcare providers and patients should contact Exactech for further information regarding the recall and potential replacement or refund options.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 386
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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