ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter
ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.
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, which typically indicates a temporary or medically reversible adverse health consequence. The defect is a dimensional manufacturing error (incorrect shaft diameter) without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
ConMed Linvatec is recalling one lot of PopLok bone punches, model PKL-35M, 3.5mm. The recall involves eight units of this orthopedic manual surgical instrument.
The recall was initiated because the metal shaft diameter of the instrument is 4.5mm, whereas it should be 3.5mm. This dimensional discrepancy affects the specified design of the surgical tool.
The affected lot, number 256058, was distributed worldwide, including in the United States (specifically California) and internationally to Spain and Korea. Users of this specific lot should stop using the instrument and contact the manufacturer for instructions.
The recalled product
- Product
- ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Affected units
- 8
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)
- Lot 256058
Distribution
Distributed in 1 state:
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