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U.S. Department of Health and Human Services

Class 2 Device Recall Smith and Nephew TWINFIX QUICKT

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  Class 2 Device Recall Smith and Nephew TWINFIX QUICKT see related information
Date Initiated by Firm June 15, 2016
Create Date July 18, 2016
Recall Status1 Terminated 3 on March 22, 2021
Recall Number Z-2218-2016
Recall Event ID 74449
Product Classification arthroscope accessory - Product Code NBH
Product Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Code Information Batch numbers: 50412843, 50477278, 50527184
Recalling Firm/
Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact
Manufacturer Reason
for Recall
The device could be subject to breaches of its sterile packaging.
FDA Determined
Cause 2
Package design/selection
Action Urgent Recall Notification Letters were sent via Federal Express on June 15, 2016, to the customers listed in the firm's distribution report. Customers were asked to inventory their devices and contact the firm for return authorizations.
Quantity in Commerce 563
Distribution Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
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.