Recall Z-2731-2011 ยท HAB Saw, Powered, And Accessories
Smith & Nephew, Inc. Endoscopy Division
DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
| Date | Jul 1, 2011 (initiated May 6, 2011) |
| Status | Terminated |
| Reason | Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use. |
| Root cause | Process control |
| Action | Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731. |
| Quantity | 744 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.