PlainRecalls
FDA Devices Moderate Class II Terminated

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Reported: July 1, 2015 Initiated: April 30, 2015 #Z-1822-2015

Product Description

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Reason for Recall

Sterility of device maybe compromised

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
202,279 units
Distribution
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.. Recalled by Smith & Nephew, Inc.. Units affected: 202,279 units.
Why was this product recalled?
Sterility of device maybe compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1822-2015.