FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or D
FDA device recall Z-0895-05 · posted 2005-06-16 · Terminated
Recall details
- Recalling firm
- FHC, Inc.
- Reason for recall
- Potential for non-sterile pin to contaminate sterile field
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 169 units
- Distribution
- Natiowide
- Date initiated
- 2005-03-14
- Date posted
- 2005-06-16
- Date terminated
- 2008-07-08
- Location
- Bowdoinham, ME
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICRO TARGETING DRIVE SYSTEM (K011775) | FHC, Inc. | 2001-08-30 |
| FHC MICROTARGETING DRIVE SYSTEM (K011992) | FHC, Inc. | 2001-08-14 |
| MICROTARGETING DRIVE SYSTEM (K003776) | FHC, Inc. | 2001-02-23 |