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Open, Classified

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

FDA Recall Z-0122-2022 · Posted None

Recalling FirmImplant Resource Inc
Recall StatusOpen, Classified
Product CodeHXL
Date Initiated2021-07-21
Product Quantity6 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

Firm 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.

Root Cause

Device Design

Distribution Pattern

US distribution to Florida and New Hampshire

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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