Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0156-2016

Z-0156-2016 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
1287 units

Product Description

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.

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

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

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

  • Z-0158-2016 Class II — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 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)