Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Enforcement
- Recall Number
- Z-0158-2016
- Event ID
- 72205
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc., Endoscopy Div.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 28, 2015
- Initiation Date
- September 10, 2015
- Classification Date
- October 22, 2015
- Termination Date
- June 23, 2021
- Address
- 130 Forbes Blvd, N/A, Mansfield, MA, 02048, United States
Description
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Sterility of device is compromised due to breach in the packaging
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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
1246 units