Exactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism
Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (gritty mechanism) that could impede surgical procedure but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 22 units of the Threaded Offset Cup Impactor, a reusable surgical instrument used to assist in the implantation of Novation hip system components for total hip replacement. The recall was initiated because the threaded mechanism of the device may be gritty and difficult to turn, a condition potentially caused by entrapped blast media.
The affected devices were distributed in the United States to hospitals and medical facilities in Arkansas, California, Florida, Illinois, Indiana, New York, South Carolina, and Texas. The recall includes devices with Catalog Number 181-02-01 and Lot Numbers 103071001 and 8182001.
Healthcare providers should stop using the affected devices and contact Exactech, Inc. for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 22
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 (2)
- Catalog Number 181-02-01
- Lot Numbers 103071001
Distribution
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