Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech is recalling 333 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the potential for significant injury associated with structural implant defects.
Plain-English summary
Exactech, Inc. is recalling 333 units of the Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52. The recall involves all lot numbers of this specific sterile, prescription medical device.
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 the offset tibial tray. This incompatibility could potentially affect the performance or safety of the implant during or after surgical use.
The affected 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 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 333
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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