The Recall Desk
HighFDA (Devices)·Z-1797-2021·Announced 2021-06-16

Medtronic Braive Growth Modulation System Break-Off Set Screws Recalled for Thread Defect

Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.

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: FDA Class II recall of a critical spinal correction medical device. Although no illnesses or injuries have been reported, the thread profile defect represents a risk-of-harm to patients relying on this device for spinal curvature management and continued skeletal growth.

Plain-English summary

Medtronic Sofamor Danek USA, Inc is recalling the Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The affected lot codes are CT20L012 (expiration 2 December 2028) and CT20L020 (expiration 11 December 2028). A total of 162 units have been affected.

This medical device is intended to limit progression of spinal curvature and provide correction of the thoracic curve in growing patients with scoliosis. The thread profile defect may affect proper device function.

The recalled devices were distributed internationally to France, Switzerland, and Jordan only. No distribution occurred in the United States.

The recalled product

Product
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Manufacturer
Medtronic Sofamor Danek USA, Inc
Category
Medical Device — Spinal Correction
Hazard
  • thread-defect
  • device-malfunction

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)

  • CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category