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Recall Observatory FDA recall evidence

Device product

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.

Z-0155-2016

September 10, 2015

Class II

Product summary

Firm
Smith & Nephew, Inc., Endoscopy Div.
Event
Event 72205
Status
Terminated
Classification
Class II
Quantity
603 units
Official record key
device-enforcement:Z-0155-2016

Official wording

Reason: Sterility of device is compromised due to breach in the packaging

Code information: Lot Numbers: 50045108 50216535 50337080 50381998 50444238 50069259 50225422 50337457 50387855 50451052 50078520 50237917 50340700 50401825 50451745 50105330 50239234 50340703 50408124 50452070 50108397 50244752 50349035 50413603 50455381 50113533 50247214 50350233 50416389 50456956 50118206 50250359 50354625 50425909 50128288 50258565 50356930 50427082 50200340 50271899 50372415 50436696 50207484 50333910 50378455 50437933

Distribution pattern: Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of device is compromised due to breach in the packaging