The Recall Desk
HighFDA (Devices)·Z-1464-2023·Announced 2023-05-03

VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect

Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device with a manufacturing defect resulting in a potential internal metal burr. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).

Plain-English summary

Covidien LP is recalling the VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS). The recall was initiated due to a manufacturing non-conformance that may result in a metal shaving or burr on the inside of the cannula where the Cannula and Body components are welded together.

No illnesses or injuries have been reported in connection with this defect. The recall affects 51 units with specific serial numbers distributed worldwide, including in North Carolina and Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, and Sweden.

The device is identified by UDI-DI: 10884521784048. Healthcare providers and facilities should verify their inventory against the recalled serial numbers provided in the FDA recall notice.

The recalled product

Product
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Manufacturer
Covidien LP
Category
Medical Device — Surgical Positioning Device
Hazard
  • metal-burr
  • manufacturing-defect

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)

  • UDI-DI: 10884521784048

Distribution

Distributed nationwide across the United States.

Related recalls

Same category