Z-0895-05

FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist...

Name: Z-0895-05 FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist...
Creator: FHC, Inc.
Published: 2005-03-14
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2005-03-14 / Terminated / root cause: sterility

FDA source

FHC, Inc. began a recall of 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) on 2005-03-14. The reason FDA records is "Potential for non-sterile pin to contaminate sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0895-05
Status: Terminated
Initiated: 2005-03-14
Posted: 2005-06-16
Terminated: 2008-07-08
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)
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Potential for non-sterile pin to contaminate sterile field
Root cause tag: sterility
FDA 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 in commerce: 169 units
Distribution: Natiowide
Product codes and lots: All codes

Product code HAW

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)