Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0155-2016

Z-0155-2016 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
603 units

Product Description

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 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

Lot Numbers: 50045108 50216535 50337080 50381998 50444238 50069259 50225422 50337457 50387855 50451052 50078520 50237917 50340700 50401825 50451745 50105330 50239234 50340703 50408124 50452070 50108397 50244752 50349035 50413603 50455381 50113533 50247214 50350233 50416389 50456956 50118206 50250359 50354625 50425909 50128288 50258565 50356930 50427082 50200340 50271899 50372415 50436696 50207484 50333910 50378455 50437933

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-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)