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Recall Observatory FDA recall evidence

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

Z-0122-2022

July 21, 2021

Class II

Product summary

Firm
Implant Resource Inc
Event
Event 88585
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0122-2022

Official wording

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

Code information: Model Number: MPR-1120-1000, Lot Number: 200911-1-1

Distribution pattern: US distribution to Florida and New Hampshire

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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