Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch
Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.
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. Per the rubric, FDA Class II recalls involving structural defects in medical devices that could cause harm are rated as Severe (4), as they carry a reasonable probability of adverse health consequences.
Plain-English summary
Exactech, Inc. is recalling 123 units of the Optetrak Logic Comprehensive Knee Prosthesis System, specifically the Proximal Tibial Spacer and screws, size 3.5, 8mm (Catalog # 02-012-42-3508). The recall covers all lot numbers for this specific catalog item.
The recall was initiated because a dimensional mismatch was identified in the devices. This defect can potentially allow for interference between devices. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed nationwide, including in Florida, Alabama, Louisiana, Pennsylvania, Virginia, Illinois, Ohio, New York, North Carolina, Kansas, Tennessee, New Jersey, Colorado, Georgia, California, Maryland, Minnesota, Indiana, and Puerto Rico. Patients who have had this specific device implanted should contact their healthcare provider for evaluation and guidance.
The recalled product
- Product
- Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
- Manufacturer
- Exactech, Inc.
- Affected units
- 123
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)
- Catalog # 02-012-42-3508 All lot numbers
Distribution
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