FDA Medical Device Recalls (openFDA)
FHC, Inc.: FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
- Recall number
- Z-0895-05
- Recalling firm
- FHC, Inc.
- Product
- FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
- Status
- Terminated
- Initiated
- 2005-03-14
- Posted
- 2005-06-16
- Terminated
- 2008-07-08
- Reason
- Potential for non-sterile pin to contaminate sterile field
- Root cause
- Other
- Action
- FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005.
- Quantity
- 169 units
- Distribution
- Natiowide
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K003776","K011775","K011992"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3002250546
- Firm city
- Bowdoinham
- Firm state
- ME
- 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