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16205-01050; 16205-01110; 60-025

Hankil Tech Medical Co., Ltd. · Model 16205-01110 · UDI-DI 08809452519205

HTJ Prescription
4
510(k) clearances
3,438
Adverse events
3
Recalls
371
Facilities

Description

Depth Gauge for ilyac, 110mm

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.