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AMD-RITMED

AMD Medicom Inc · Model 2214 · UDI-DI 10686864042799

LWH
10
510(k) clearances
580
Adverse events
4
Recalls
48
Facilities

Description

AMD-RITMED COUNTWAY INNER BAGS

Recalls

DateFirmReason
2026-03-19United Orthopedic Corp.Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2022-06-15Stryker Instruments Div. of Stryker CorporationWhen 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.
2016-03-21Stryker Instruments Div. of Stryker CorporationThe 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).
2013-06-16Stryker Instruments Div. of Stryker CorporationFaulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

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Data 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.