Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0158-2016

Z-0158-2016 Class II Terminated

Recalled by Smith & Nephew, Inc., Endoscopy Div. — Mansfield, MA

Recall Details

Product Type
Devices
Report Date
October 28, 2015
Initiation Date
September 10, 2015
Termination Date
June 23, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1246 units

Product Description

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.

Reason for Recall

Sterility of device is compromised due to breach in the packaging

Distribution Pattern

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

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

Other recalls by Smith & Nephew, Inc., Endoscopy Div.

  • Z-0156-2016 Class II — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Pa (September 10, 2015)
  • Z-0155-2016 Class II — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Pa (September 10, 2015)
  • Z-0157-2016 Class II — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Pa (September 10, 2015)
  • Z-0818-2016 Class II — High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories (July 30, 2013)
  • Z-0700-2016 Class II — Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of ortho (April 4, 2013)
  • Z-0699-2016 Class II — Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic sc (April 4, 2013)