FDA Medical Device Recalls (openFDA)
Implant Resource Inc: 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
- Recall number
- Z-0122-2022
- 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
- Status
- Open, Classified
- Initiated
- 2021-07-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
- 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
- 6 units
- Distribution
- US distribution to Florida and New Hampshire
- Lot, serial or model codes
- Model Number: MPR-1120-1000, Lot Number: 200911-1-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXL
- Firm FEI
- 1000139815
- Firm city
- Eagan
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28