Recall Z-2047-2014
Smith & Nephew, Inc. Endoscopy Division · initiated June 2, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Codes / lots: Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899
Reason for recall
Sterility of device is compromised due to breach in sterile barrier
FDA-determined 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.
Details
- Recall number
- Z-2047-2014
- Initiated
- June 2, 2014
- Posted by FDA
- July 14, 2014
- Terminated
- September 15, 2017
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 907 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2045-2014 Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener…Sterility of device is compromised due to breach in sterile barrier | 06/02/2014Terminated |
| Z-2046-2014 Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842…Sterility of device is compromised due to breach in sterile barrier | 06/02/2014Terminated |
| Z-2048-2014 Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853…Sterility of device is compromised due to breach in sterile barrier | 06/02/2014Terminated |
| Z-2049-2014 Class II | SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation…Sterility of device is compromised due to breach in sterile barrier | 06/02/2014Terminated |