Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech, Inc. is recalling 411 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 involves a design incompatibility in a medical device that could lead to improper function or injury, but the source text does not report any specific illnesses, injuries, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 411 units of the Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82. The devices are sterile and prescription-only. The recall covers all lot numbers of this specific product size.
The recall was initiated 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 an offset tibial tray. This incompatibility may affect the proper function of the implant system.
The affected devices were distributed to hospitals and clinics 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 further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 411
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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