Recall Z-0158-2016 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Smith & Nephew, Inc., Endoscopy Div.
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.
| Date | Oct 22, 2015 (initiated Sep 10, 2015) |
| Status | Terminated |
| Reason | Sterility of device is compromised due to breach in the packaging |
| Root cause | Package design/selection |
| Action | Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & |
| Quantity | 1246 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964215 | ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM Smith & Nephew Endoscopy, Inc., Dec 20, 1996 |