Fischer Cone Biopsy Excisor - Small Model: 900-150
FDA device recall Z-0614-06 · posted 2006-04-06 · Terminated
Recall details
- Recalling firm
- Apple Medical Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HGI
- Quantity affected
- 1,602.7 boxes
- Distribution
- Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
- Date initiated
- 2006-03-10
- Date posted
- 2006-04-06
- Date terminated
- 2016-03-07
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LWEET CONE BIOPSY INSTRUMENT (K961460) | Apple Medical Corp. | 1996-11-19 |