Recall Z-0122-2022— Implant Resource Inc
Class II · Ongoing
Class II FDA medical device recall by Implant Resource Inc, initiated 2021-07-21. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected.
- Recalling firm
- Implant Resource Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-07-21
- Firm location
- Eagan, MN, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.