FDA Medical Device Recalls (openFDA)
Apple Medical Corporation: Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
- Recall number
- Z-0618-06
- Recalling firm
- Apple Medical Corporation
- Product
- Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
- Status
- Terminated
- Initiated
- 2006-03-10
- Posted
- 2006-04-06
- Terminated
- 2016-03-07
- 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
- 831.0 boxes
- Distribution
- Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
- Lot, serial or model codes
- Lot Numbers: D201710, A2005, D205004, D218913, D229701, D304806, D307910, D316307, H213D, J073C, L153Q, A134B
- 510(k) numbers
- ["K961460"]
- PMA numbers
- not on file
- Product code
- HGI
- Firm FEI
- 1216677
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28