Z-1797-2021Class II

Braive Growth Modulation System Break-Off Set Screws -

Name: Z-1797-2021 Braive Growth Modulation System Break-Off Set Screws -
Creator: Medtronic Sofamor Danek USA, Inc
Published: 2021-04-27
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2021-04-27 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA, Inc began a recall of Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of... on 2021-04-27. FDA classified it as Class II and gives the reason as "Product is impacted by a thread profile defect due to a manufacturing issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1797-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-27
Posted: 2021-06-04
Terminated: 2024-08-20
Recalling firm: Medtronic Sofamor Danek USA Inc
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.
Product code: MRW System, Facet Screw Spinal Device
Reason for recall: Product is impacted by a thread profile defect due to a manufacturing issue.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 4/26/2021 the firm sent a letter to its consignees with the following instructions: Required Actions: 1) Identify, segregate, and quarantine any impacted product (listed above) within your inventory. 2) Return the impacted product to Medtronic. Your Medtronic Sales Representative can assist in facilitating the return of product as necessary. 3) Please maintain a copy of this notice in your records. 4) Please share this communication within your organization, with other organizations where affected devices have been transferred, and any other associated organizations that may be impacted by this action.
Quantity in commerce: 162 UNITS
Distribution: International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Product codes and lots: CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1797-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1797-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04

Product code MRW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)