Recall Z-1822-2015
Smith & Nephew, Inc. · initiated April 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Codes / lots: All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
Reason for recall
Sterility of device maybe compromised
FDA-determined cause: Package design/selection
Action taken
Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number
Details
- Recall number
- Z-1822-2015
- Initiated
- April 30, 2015
- Posted by FDA
- June 22, 2015
- Terminated
- September 19, 2017
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Quantity
- 202,279 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar…
- Recalling firm
- Smith & Nephew, Inc., Andover, MA