Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 953 Optetrak Constrained Condylar Offset Screws because they are design-incompatible with certain tibial inserts and trays.
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 vehicle defect equivalent (design incompatibility in a load-bearing orthopedic implant), which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Exactech, Inc. is recalling 953 units of the Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74. The recall covers all lot numbers of this sterile, prescription-only medical device.
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 with an offset tibial tray. This issue affects the structural integrity or proper function of the implant components when combined.
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 these devices and contact Exactech for instructions on return or replacement.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Affected units
- 953
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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