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Terminated

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.

FDA Recall Z-2075-2015 · Posted 2015-07-15

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusTerminated
Product CodeHXY
Date Initiated2015-05-27
Date Terminated2017-05-08
Product Quantity117 units

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.

Firm Action

Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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