FDA Device recall Z-1380-2021
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the pro…
- FDA Device
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the pro… by Arthrex, citing it was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1380-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-11 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arthrex |
| Distribution | US |
Product
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Reason
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Identifiers
| code_info | Part number: AR-13200T-15.0; Lot code:12135408 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1380-2021%22
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