Recall Z-2075-2015— Musculoskeletal Transplant Foundation, Inc.
Class II · Terminated
Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2015-05-27, terminated 2017-05-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-27
- Terminated
- 2017-05-08
- Firm location
- Edison, NJ, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.