MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com
Summary
The FDA issued a Class II for MPR Slotted Mallet, labeling etched onto devices as follows: Medical Product by Implant Resource Inc. Reason: Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected.
Details
Source
Device Recall
External ID
Z-0122-2022
Action Date
2021-10-27
Status
Ongoing
Category
device
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
Lot/Code Info: Model Number: MPR-1120-1000, Lot Number: 200911-1-1
Quantity Affected: 6 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-21
Company
Eagan, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Implant Resource Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Implant Resource Inc have FDA actions?
This is the only FDA action we have on record for Implant Resource Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0122-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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