Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 656 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. The hazard involves a design incompatibility in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Exactech, Inc. is recalling 656 units of the Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77. 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.
Healthcare providers should stop using the affected devices and contact Exactech for further instructions. Patients who have had these devices implanted should contact their surgeon to discuss the potential implications of the design incompatibility.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 656
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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