Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Recall Initiated
- September 10, 2015
- Posted
- October 22, 2015
- Terminated
- June 23, 2021
- Recall Number
- Z-0156-2016
- Quantity
- 1287 units
- Firm Location
- Mansfield, MA
Reason for Recall
Sterility of device is compromised due to breach in the packaging
Distribution
Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
Lot / Code Info
50051865 50218987 50317627 50353758 50405160 50451743 50481584 50067670 50230666 50322491 50361146 50408123 50452778 S603582 50081261 50234894 50329870 50372414 50411652 50455378 50120770 50238931 50331389 50376694 50415117 50456676 50121527 50242557 50335918 50379781 50418789 50458024 50180302 50248824 50337463 50381854 50419542 50460414 50194727 50253762 50340709 50383822 50419729 50462250 50204111 50257419 50340713 50387833 50427066 50465245 50207090 50277081 50345713 50390055 50428661 50476968 50209127 50285673 50348084 50395389 50448620 50481431
Root Cause
Package design/selection
Action Taken
Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.