Recall Z-0122-2022 ยท HXL Mallet
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
| Date | Jul 21, 2021 |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.