Recall Record

Eagan, MN, United States

Implant Resource Inc recalls

1 recall recorded since 2018, most recently on 21 July 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
21 July 2021
Reason
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
Initiated
Voluntary: Firm initiated
Recall number
Z-0122-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.