Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0157-2016

Z-0157-2016 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
1347 units

Product Description

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 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

567531 50182767 50242031 50311086 50354626 50396028 50419909 50451050 50481583 586717 50193108 50251239 50311900 50361147 50400191 50423797 50451742 L50195027 50023445 50195027 50254749 50322127 50372399 50402518 50427083 50452777 50031093 50200477 50257710 50326789 50375128 50404802 50431408 50455222 50089906 50207485 50260093 50331945 50376693 50405482 50432856 50456255 50112893 50214248 50266143 50337081 50379780 50408076 50433676 50460255 50129647 50218992 50279513 50337265 50381258 50408437 50442599 50469461 50160551 50221872 50285674 50337464 50389830 50411651 50443725 50476967 50175558 50230673 50297948 50344790 50389832 50414388 50447281 50477073 50179006 50236269 50302624 50348085 50395177 50414909 50448747 50480681

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-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-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)