Recall Z-0082-2012 ยท GCJ Laparoscope, General & Plastic Surgery
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
| Date | Oct 21, 2011 (initiated Sep 23, 2011) |
| Status | Terminated |
| Reason | HD1200 camera heads may cause image issues |
| Root cause | Process design |
| Action | Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. For questions call 405-917-8556. |
| Quantity | 15 units |
| Distribution | Nationwide Distribution (USA) including the states of: MI, NH, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014158 | ENDOSCOPIC CAMERA TC804/C4 World of Medicine Lemke GmbH, Mar 14, 2002 |