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CARDINAL HEALTH

Cardinal Health 200, LLC · Model CH02-0001 · UDI-DI 10885380083068

HTJ Prescription
4
510(k) clearances
3,468
Adverse events
3
Recalls
371
Facilities

Description

Cannulated Screw Measuring Device For 3.5mm & 4.0mm Screws

Recalls

DateFirmReason
2019-05-28Zimmer Biomet, Inc.There is a potential for weak seals of the sterile packaging.
2011-01-27Stryker Howmedica Osteonics Corp.Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition)
2009-12-22Stryker Howmedica Osteonics Corp.The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.

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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.