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CAPTURE™

Ascension Orthopedics, Inc. · Model AI-5050 · UDI-DI 10381780242000

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

Description

CAPTURE™ High Torque Screw System The combination Countersink and Depth Gauge allows for precise measurement. This tool is used with 4.0/5.0mm 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.