Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error
Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.
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 is a labeling error (transposed labels) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 26 units of Novation Crown Cup Connection GXL Neutral Liners (Catalog No. 130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners (Catalog No. 136-32-53). These medical devices are indicated for use in surgery for hip replacement.
The recall was initiated because Exactech discovered that the device labeling was inadvertently transposed. The affected units include Serial Numbers 2479944 through 2479969 for Catalog No. 130-32-53 and Serial Numbers 2479873 through 2479898 for Catalog No. 136-32-53.
The devices were distributed in the states of Tennessee, Florida, Virginia, Washington, and Nevada. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 26
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 (3)
- Catalog No. 130-3253
- Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53
- Serial Numbers 2479873 - 2479898.
Distribution
Part of a larger recall action
This product is one of 2 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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