FDA Device recall Z-1592-2026
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032…
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032… by I T S, citing updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1592-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-23 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | I T S |
| Distribution | US |
Product
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Reason
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Identifiers
| code_info | Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/0325…Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/032501, 643/072503, 643/102501), 21031-5 (43/0015, 643/102201, 643/102201, 679/0323121, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 643/102201, 643/102201, 643/102201, 643/102201, 679/0323120, 679/0323120), 21032-11 (679/112312), 21032-3 (679/032241, 643/0623, 679/042293, 679/0323122, 679/062367, 679/052318, 643/022501, 643/062501, 643/072501, 643/102502), 21032-5 (679/122136, 679/0323143, 679/042337), 21033-3 (679/062212, 679/022301, 679/042338, 679/022302), 21033-5 (643/0629, 26/F24901, 679/012311), 21034-3 (679/062221, 679/012312, 679/072217, 679/042339), 21034-5 (643/102202, 679/012314, 679/012313), 21035-3 (679/062222, 679/042308, 643/012501, 643/0548), 21036-3 (679/062213, 679/042309, 679/112317), |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1592-2026%22
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