Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech, Inc. is recalling 520 Optetrak Constrained Condylar Offset Screws due to a design incompatibility 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural or design defects in medical devices.
Plain-English summary
Exactech, Inc. is recalling 520 units of the Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80. 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 an offset tibial tray.
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. 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, Inc. for further instructions. The FDA has classified this recall as Class II, meaning it may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 520
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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