Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 606 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 design incompatibility in a medical device 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 606 units of the Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76. 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.
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 instructions on return or replacement.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 606
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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