FDA Device recall Z-2255-2019
Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System by Biopro, citing manufacturing flaw in the sterile barrier system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-25 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biopro |
| Distribution | US |
Product
Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Reason
Manufacturing flaw in the sterile barrier system
Identifiers
| code_info | UDI - M209196690 Lot Number - 123116 MFG Date - 4/26/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2019%22
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