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Recall Observatory FDA recall evidence

Device product

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

Z-1822-2015

April 30, 2015

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 71257
Status
Terminated
Classification
Class II
Quantity
202,279 units
Official record key
device-enforcement:Z-1822-2015

Official wording

Reason: Sterility of device maybe compromised

Code information: All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of device maybe compromised