FDA Device recall Z-0828-2020
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
- FDA Device
- Class II
- ongoing
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 by Medicrea International, citing conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-16 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medicrea International |
| Distribution | US |
Product
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Reason
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Identifiers
| code_info | Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2020%22
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