FDA-Device2021-10-27Class II

MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

Implant Resource Inc
Hazard

Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

Sold states
US distribution to Florida and New Hampshire
Affected count
6 units
Manufactured in
917 Lone Oak Rd Ste 1000, N/A, Eagan, MN, United States
Products
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2022

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