Reported Jul 22, 2015 · Terminated

Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific…

Musculoskeletal Transplant Foundation, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Musculoskeletal Transplant Foundation, Inc. · 125 May St Ste 300 · Edison, NJ · 08837-3264

Is this the product you have?

  • Allofix Insertion Kit, 2.0 mm, Single Drill
  • Product UsageMTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only
Lot codes and dates
  • Product Code
    • 900920
    • Serial #:906912041001
    • Expiry date 01Mar2017
Amount recalled
117 units

Where it was sold

Why it was recalled

Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2017 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.