Exactech Recalls Hip Replacement Liners Due to Labeling Error
Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.
What this means for you
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 identifies the issue as a labeling transposition without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk issues where harm has not been reported.
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). The recall was initiated because the company discovered that the device labeling was inadvertently transposed.
The affected devices are indicated for use in surgery for hip replacement. The specific units involved include Serial Numbers 2479944 through 2479969 for Catalog No. 130-32-53 and Serial Numbers 2479873 through 2479898 for Catalog No. 136-32-53.
These devices were distributed in the states of Tennessee, Florida, Virginia, Washington, and Nevada. The source text does not specify further instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- Product
- Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. 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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