Home / Recalls / Smith & Nephew, Inc., Endoscopy Div. / Z-0818-2016

Z-0818-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
February 24, 2016
Initiation Date
July 30, 2013
Termination Date
February 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
203 units

Product Description

High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

Reason for Recall

During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.

Distribution Pattern

Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.

Code Information

50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254

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-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)