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

Is my product affected?

Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF 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.

• UPC 906912041001

Check against the official notice below — it lists the full affected range.

What happened

Musculoskeletal Transplant Foundation, Inc. is recalling 117 units of Allofix Insertion Kits (Product Code 900920, Serial #906912041001, expiring March 1, 2017) because the kits are labeled as containing a 2.0mm diameter drill but may instead contain a 2.4mm diameter drill. The affected products were distributed nationwide across 16 states: Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Utah, Washington, and West Virginia.

The mislabeled drill size could result in improper sizing for surgical procedures. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. 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. Quantity: 117 units Lot/code info: Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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