Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 889 Optetrak Constrained Condylar Offset Screws because they are incompatible 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 involves a medical device with a design incompatibility that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Exactech, Inc. is recalling 889 units of the Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72. The recall covers all lot numbers of this specific sterile, prescription device.
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 with an offset tibial tray. This incompatibility could affect the proper function of the knee implant system.
The devices were distributed to hospitals and clinics in Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. They were also distributed to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. Healthcare providers should stop using these devices and contact Exactech for instructions on return or replacement.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 889
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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