Z-0122-2022Class II

MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194...

Name: Z-0122-2022 MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194...
Creator: Implant Resource Inc
Published: 2021-07-21
License: https://open.fda.gov/license/

Implant Resource Inc / initiated 2021-07-21 / Open, Classified / root cause: design

FDA source

Implant Resource Inc began a recall of 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 on 2021-07-21. FDA classified it as Class II and gives the reason as "Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0122-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-21
Posted: 2021-10-16
Recalling firm: Implant Resource Inc
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
Product code: HXL Mallet
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
Root cause tag: design
FDA root cause: 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
Product codes and lots: Model Number: MPR-1120-1000, Lot Number: 200911-1-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0122-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0122-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-15

Product code HXL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)