FDAClass IIJuly 22, 2015

Allofix Insertion Kit recall

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

Why was Allofix Insertion Kit 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017

Product
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and…
Recalling firm
Musculoskeletal Transplant Foundation, Inc.
Quantity
117 units
Distribution
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls