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Terminated

Fischer Cone Biopsy Excisor Model: 900-157

FDA Recall Z-0620-06 · Posted 2006-04-06

Recalling FirmApple Medical Corporation
Recall StatusTerminated
Product CodeHGI
Date Initiated2006-03-10
Date Terminated2016-03-07
Product Quantity129 boxes (10 each)

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.

K961460LWEET CONE BIOPSY INSTRUMENTApple Medical Corp. · 1996-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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