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ORLocate
STERIS CORPORATION · Model ORLocate Components Pack · UDI-DI 00724995245290
1
510(k) clearances
580
Adverse events
4
Recalls
48
Facilities
Description
The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.