FDA recall Z-0122-2022

Implant Resource Inc · Class II · device

Product

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

Reason for recall

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

Distribution

US distribution to Florida and New Hampshire

Key facts

Status
Ongoing
Initiation date
2021-07-21
Report date
2021-10-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eagan, MN, United States

Primary source

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