Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: September 10, 2015
• Date Posted: October 22, 2015
• Recall Status: Terminated on June 23, 2021
• Recall Number: Z-0158-2016
• Recall Event ID: 72205
• 510(K)Number: K964215
• Product Classification: Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
• Product: Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
• Code Information: 50069280 50214249 50260936 50334160 50380067 50410625 50442600 50084563 50217938 50266144 50337465 50383809 50412120 50448621 50097669 50227860 50276674 50352665 50385382 50415177 50451051 50112174 50231228 50282533 50353524 50389835 50416603 50451744 50117989 50236270 50310331 50356943 50391478 50424410 50452069 50131406 50242373 50317889 50362696 50396029 50428473 50455380 50139181 50246739 50320168 50370396 50399036 50428686 50457280 50148410 50254144 50324084 50372214 50401621 50432549 50461109 50199543 50254145 50328908 50374300 50404803 50436553 50469462 50203454 50258249 50332285 50378312 50407329 50436675 50475144 50481307
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc., Endoscopy Div.; 130 Forbes Blvd; Mansfield MA 02048
• For Additional Information Contact: Same; 978-749-1000
• Manufacturer Reason for Recall: Sterility of device is compromised due to breach in the packaging
• FDA Determined Cause: Package design/selection
• Action: 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.
• Quantity in Commerce: 1246 units
• 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
• 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.

• 510(K) Database: 510(K)s with Product Code = HWE