Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and 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, which typically corresponds to a High severity score (3) when no specific hospitalizations or serious injuries are reported in the source text, representing a risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Exactech, Inc. is recalling 306 units of Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX. The recall involves all lot numbers of this specific device configuration.
The recall is being conducted 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. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The 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 stop using the affected devices and contact Exactech for further instructions.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 306
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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