FHC 66-ZD-MD microTargeting Drive System: System for… recallZ-0895-05 · FHC, Inc. · initiated Mar 14, 2005
Terminated All recalls posted in June 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for non-sterile pin to contaminate sterile field
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0895-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 14, 2005
- Posted by the FDA
- Jun 16, 2005
- Recalling firm
- FHC, Inc.
- Quantity
- 169 units
- Product code
- HAW
- FDA submissions
- K003776, K011775, K011992
- Distribution
- Natiowide
Product description
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)
Code information (models, lots, serial numbers)
All codes
Other devices under the same FDA submission
8 devices cleared under K003776, K011775, K011992 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- microTargeting™ Insertion Tube Set 66-IT-05P-00432Fhc, Inc. · Neurological stereotaxic Instrument1 recall1 report
- microTargeting™ Drive System FC1006-00147Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive System MT-DS-01-00350Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive System MT-DS-00352Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive 66-ZD-MD-01-00356Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive 66-ZD-MD-00357Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive DBS Adapter 66-CN-DB-00453Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Sterile Drape Sleeve 66-DA-SD-00436Fhc, Inc. · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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