Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
Exactech is recalling 893 Optetrak Offset Tibial Trays and Screws because of a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
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 describes a design incompatibility in a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Exactech, Inc. is recalling 893 units of the Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24. The recall affects all lot numbers of this sterile, prescription-only medical device.
The recall was initiated 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 the offset tibial tray. This issue is specific to the interaction of these components within the device system.
The devices were distributed to hospitals and medical facilities in Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. International 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 for instructions on how to handle the recalled devices.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 893
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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