HXLClass I

Mallet

General, Plastic Surgery · 21 CFR 878.4800

MDR events73All time

Recalls1All time

Registered firms202Currently listed

510(k) clearances3All time

Recent MDR events

73 adverse event reports on file

Event type breakdown

Malfunction63

Injury6

Unspecified4

Most-reported manufacturers

Teleflex Medical12 Synthes Gmbh5 Aesculap Ag4 Carefusion3 Howmedica Inc.3 Zimmer, Inc.3 Integra York, Pa Inc.2 Jarit2

Recalls

1 recall events for this product code

Implant Resource Inc
Open, ClassifiedUnknown
MPR Slotted Mallet, labeling etched onto devices as follows:
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Z-0122-2022 · View FDA record ↗

Registered firms

202 firms currently registered for this product code

510(k) clearances

3 clearances for this product code