Recall Z-0614-06 ยท HGI Electrocautery, Gynecologic (And Accessories)
Apple Medical Corporation
Fischer Cone Biopsy Excisor - Small Model: 900-150
| Date | Apr 6, 2006 (initiated Mar 10, 2006) |
| Status | Terminated |
| Reason | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. |
| Root cause | Other |
| Action | Apple Medical Corporation issued letters dated March 21, 2006 to direct accounts and distributors via US Mail. Distributors are requested to sub-recall. Product is to be returned to the firm and destroyed. |
| Quantity | 1,602.7 boxes |
| Distribution | Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961460 | LWEET CONE BIOPSY INSTRUMENT Apple Medical Corp., Nov 19, 1996 |