Z-0614-06

Fischer Cone Biopsy Excisor - Small Model: 900-150

Name: Z-0614-06 Fischer Cone Biopsy Excisor - Small Model: 900-150
Creator: Apple Medical Corporation
Published: 2006-03-10
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2006-03-10 / Terminated

FDA source

Apple Medical Corporation began a recall of Fischer Cone Biopsy Excisor - Small Model: 900-150 on 2006-03-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0614-06
Status: Terminated
Initiated: 2006-03-10
Posted: 2006-04-06
Terminated: 2016-03-07
Recalling firm: CooperSurgical, Inc.
Product: Fischer Cone Biopsy Excisor - Small Model: 900-150
Product code: HGI Electrocautery, Gynecologic (And Accessories)
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.
FDA 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 in commerce: 1,602.7 boxes
Distribution: Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
Product codes and lots: Lot Numbers: A2001, D201702, D209314, D211316, D218411 D220313, D225216, D230104, D301326, D302104 C143D, C213H, D307908, D313505, E193, D316303 G293, H213, I153C, J283, K063L, L153N, A134F

Product code HGI

K961460Class IILweet Cone Biopsy InstrumentApple Medical Corp. / cleared 1996-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)