Recall Z-1797-2021 ยท MRW System, Facet Screw Spinal Device
Medtronic Sofamor Danek USA, Inc
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.
| Date | Apr 27, 2021 |
| Status | Terminated |
| Reason | Product is impacted by a thread profile defect due to a manufacturing issue. |
| 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 |
| Quantity | 162 UNITS |
| Distribution | International distribution in the countries of France, Switzerland and Jordan. No US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.