Recall Z-1564-2009 ยท NBH Accessories, Arthroscopic
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Endoscopic Disposable Blades: DISPOSABLE BL,4.5MM FR ELITE Part #: 7210499. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
| Date | Jul 14, 2009 (initiated May 7, 2009) |
| Status | Terminated |
| Reason | Product sterility is compromised due to breach in the sterile packaging. |
| Root cause | Pending |
| Action | Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655. |
| Quantity | 906 units |
| Distribution | Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.