Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
Exactech, Inc. is recalling 733 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a structural design incompatibility in a load-bearing orthopedic implant, which aligns with the rubric criteria for structural vehicle defects or significant injury risks.
Plain-English summary
Exactech, Inc. is recalling 733 units of the Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31. 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 in conjunction with the 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. The recall covers all lot numbers.
Healthcare providers should stop using the affected devices and contact Exactech, Inc. for further instructions. Patients who have had these devices implanted should consult their orthopedic surgeon regarding the potential impact of this design incompatibility.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 733
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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