Fischer Cone Biopsy Excisor - Large Model: 900-152
FDA Recall Z-0616-06 · Posted 2006-04-06
Recalling FirmApple Medical Corporation
Recall StatusTerminated
Product CodeHGI
Date Initiated2006-03-10
Date Terminated2016-03-07
Product Quantity1,845.0 boxes
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.