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Mallet

FDA product code HXL · Class 1 · General, Plastic Surgery

558

Registered devices

73

Adverse events

1

Recalls

3

510(k) clearances

Devices with this code

MSI Precision Specialty Instruments — Med Saver, Inc.Main-Mallet — Mainstream Medical Devices, LLC AESCULAP — Aesculap AG Mallet — Osteocentric Technologies, Inc.Tecomet — TECOMET INC.MALLET — SONTEC INSTRUMENTS, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATION Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATION Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATION Surgical Direct — Surgical Direct, Inc.Disc Preparation Instruments — Highridge Medical, LLC SPINAL MALLET — SONTEC INSTRUMENTS, INC.General Instrument — ALPHATEC SPINE, INC.SONTEC MALLET — SONTEC INSTRUMENTS, INC.General Instruments — ALPHATEC SPINE, INC.BONE MALLET — SONTEC INSTRUMENTS, INC.General Instruments — ALPHATEC SPINE, INC.MSI Precision Specialty Instruments — Med Saver, Inc.STILLE Mallets — Stille AB Marina Medical — MARINA MEDICAL INSTRUMENTS, INC.Affixus® — Zimmer, Inc.Surgical Direct — Surgical Direct, Inc.MSI Precision Specialty Instruments — Med Saver, Inc.MSI Precision Specialty Instruments — Med Saver, Inc.

Recent recalls

Date	Firm	Reason
2021-07-21	Implant Resource Inc	Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.