Exactech Recalls Two Novation Ceramic Hip Acetabular Cups
Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.
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, but the source text indicates a procedural error (packaging before approval) rather than a physical defect or reported injury, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling two units of the Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56. These devices are intended for use in primary total hip arthroplasty.
The recall was initiated because the devices were inadvertently sent to packaging and finished goods prior to the approval of the PMA site-change supplement. The affected units have Serial Numbers 4268399 and 4268400 and an expiration date of 2/6/2021.
The devices were distributed in Florida, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee, Virginia, and Hawaii. Healthcare providers and patients should contact Exactech for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
- Manufacturer
- Exactech, Inc.
- Affected units
- 2
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 (4)
- Product Code: MRA
- Catalog Number 140-01-56
- Serial Numbers: 4268399 and 4268400
- Exp. 2/6/2021.
Distribution
Part of a larger recall action
This product is one of 6 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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