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Recall Observatory FDA recall evidence

Device 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 are intended to be used in conjunction with the associated allograft. This kit is for single use only.

Z-2075-2015

May 27, 2015

Class II

Product summary

Firm
Musculoskeletal Transplant Foundation, Inc.
Event
Event 71559
Status
Terminated
Classification
Class II
Quantity
117 units
Official record key
device-enforcement:Z-2075-2015

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.