Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0700-2016

Z-0700-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
February 10, 2016
Initiation Date
April 4, 2013
Termination Date
March 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

Product Description

Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument

Reason for Recall

Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.

Code Information

Lot Numbers: 50410950 and 50407175

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-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-0699-2016 Class II — Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic sc (April 4, 2013)