The Recall Desk
ModerateFDA (Devices)·Z-2147-2012·Announced 2012-08-15

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.

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. 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.
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

Distributed nationwide across the United States.

The notice also names 2 states specifically: