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Medtronic Resuable Instruments

MEDTRONIC SOFAMOR DANEK, INC. · Model X0315037 · UDI-DI 00643169629233

HTJ Prescription
4
510(k) clearances
3,468
Adverse events
3
Recalls
375
Facilities

Description

CALIPER X0315037 MEASURING

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.