FDA Device recall Z-2242-2019
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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 K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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-2242-2019 |
| 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
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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 - M209OL17025S0 Lot Number - 123218 MFG Date - 4/24/2019 |
|---|
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-2242-2019%22
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