The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0122-2022·Announced 2021-10-27

MPR Slotted Mallet recalled for potential head separation

Implant Resource Inc is recalling the MPR Slotted Mallet (Model MPR-1120-1000, Lot 200911-1-1) due to potential separation of the mallet head from the handle and unexpected deformations on the striking surface.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm surgical instrument where component failure (mallet head separation) could occur during use, and unexpected deformations may affect tool performance. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a High-severity recall for a risk-of-harm product with no reported injury.

Plain-English summary

Implant Resource Inc is recalling the MPR Slotted Mallet, Model MPR-1120-1000 (Lot Number 200911-1-1), distributed to medical facilities in Florida and New Hampshire. The recall was initiated due to two identified defects: the potential for the mallet head to become separated from the mallet handle during use, and significant unexpected deformations on the striking surface.

The mallet is a surgical instrument used in implant procedures. The separation of the head from the handle could result in loss of the tool during a procedure, while the surface deformations may affect the tool's intended performance and reliability.

A total of 6 units were distributed. Customers who have received this product should stop using it and contact Implant Resource Inc at 800.524.5194 or the FDA for instructions on return or replacement.

The recalled product

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
Manufacturer
Implant Resource Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number: MPR-1120-1000
  • Lot Number: 200911-1-1

Distribution

Distributed in 2 states:

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