Class 2 Device Recall QuickGraft

• Date Initiated by Firm: August 15, 2019
• Create Date: September 20, 2019
• Recall Status: Terminated on July 01, 2020
• Recall Number: Z-2548-2019
• Recall Event ID: 83644
• 510(K)Number: K181633
• Product Classification: Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
• Product: QuickGraft Model # 430PST
• Code Information: Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056
• Recalling Firm/ Manufacturer: Musculoskeletal Transplant Foundation, Inc.; 125 May St Ste 300; Edison NJ 08837-3264
• For Additional Information Contact: MTF Customer Service Department; 800-433-6576
• Manufacturer Reason for Recall: Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: You may choose to add the additional label to the unit(s), this may be completed by an appropriate Sales Representative or hospital staff. Or, you may choose to have the unit(s) returned to MTF for the labelling correction
• Quantity in Commerce: 9 Qty
• Distribution: NY NC LA TX MO OH
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAT