FDA Device recall Z-2153-2024
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 by Howmedica Osteonics, citing the design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2153-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-23 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Reason
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Identifiers
| code_info | Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2024%22
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