Device product
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Z-1822-2015
Product summary
- 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
Sterility of device maybe compromised