ConMed Linvatec Recalls CrossFT Punch Due to Incorrect Etching
ConMed Linvatec is recalling 2 units of the CrossFT Punch (Lot #156920) because the device may have incorrect item numbers and depth lines.
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. The hazard involves incorrect labeling and depth lines on a surgical instrument, which is a significant defect but does not meet the criteria for Severe (Class I or structural defect) or High (high-risk pathogens).
Plain-English summary
ConMed Linvatec is recalling two units of the CrossFT Punch, Product Number PFT-45M, Lot #156920. The device is intended to create a hole to facilitate the insertion of the CrossFT suture anchor into bone.
The recall was initiated because there is a possibility that the device was etched incorrectly. Specifically, the item number may be listed as PFT-00M instead of PFT-45M, and the device may include incorrect depth lines for insertion.
The affected products were distributed nationwide, including in Colorado and Pennsylvania. The source text does not specify further instructions for consumers or healthcare providers regarding the handling of these specific units.
The recalled product
- Product
- CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- 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 (1)
- Lot #156920
Distribution
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