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Alleset
GRI Medical & Electronic Technology Co., Ltd. · Model Model 25-2990 · UDI-DI 16931918140452
10
510(k) clearances
581
Adverse events
4
Recalls
48
Facilities
Description
Sponge counter bag_ 96cm*25.5cm_Non-sterile_250ea/cs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | United Orthopedic Corp. | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| 2022-06-15 | Stryker Instruments Div. of Stryker Corporation | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. |
| 2016-03-21 | Stryker Instruments Div. of Stryker Corporation | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). |
| 2013-06-16 | Stryker Instruments Div. of Stryker Corporation | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. |
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