DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
This recall has been terminated (originally issued July 1, 2011).
- Recall Initiated
- May 6, 2011
- Posted
- July 1, 2011
- Terminated
- May 9, 2012
- Recall Number
- Z-2732-2011
- Quantity
- 555 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
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.
Lot / Code Info
Lot Number: 50561144
Root Cause
Process control
Action Taken
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.