SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
This recall has been terminated (originally issued July 14, 2014).
- Recall Initiated
- June 2, 2014
- Posted
- July 14, 2014
- Terminated
- September 15, 2017
- Recall Number
- Z-2047-2014
- Quantity
- 907 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of device is compromised due to breach in sterile barrier
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Lot / Code Info
Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899
Root Cause
Package design/selection
Action Taken
Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.