Z-0122-2022 Class II Ongoing
FDA device recall Z-0122-2022 was initiated by Implant Resource Inc on July 21, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- July 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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
Distribution Pattern
US distribution to Florida and New Hampshire
Code Information
Model Number: MPR-1120-1000, Lot Number: 200911-1-1