Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Slotted Mallet

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Slotted Mallet see related information
Date Initiated by Firm July 21, 2021
Create Date October 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0122-2022
Recall Event ID 88585
Product Classification Mallet - Product Code HXL
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
Code Information Model Number: MPR-1120-1000, Lot Number: 200911-1-1
Recalling Firm/
Manufacturer		 Implant Resource Inc
917 Lone Oak Rd Ste 1000
Eagan MN 55121-2266
For Additional Information Contact Ben Hanson
952-277-1257
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action Customers were initially contacted via email on 07/21/2021 to initiate the return of affected devices. A formal letter was sent to customers on 09/03/2021 via UPS. Instructions included to review the notification and ensure affected personnel are notified of the recall, immediately locate and quarantine any affected product in inventory, and to immediately return any affected product to Medical Products Resource.
Quantity in Commerce 6 units
Distribution US distribution to Florida and New Hampshire
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-