| Date Initiated by Firm | March 14, 2005 |
|---|
| Date Posted | June 16, 2005 |
|---|
| Recall Status1 |
Terminated 3 on July 08, 2008 |
| Recall Number | Z-0895-05 |
|---|
| Recall Event ID |
31718 |
| 510(K)Number | K003776 K011775 K011992 |
|---|
| Product Classification |
Neurological Stereotaxic Instrument - Product Code HAW
|
| 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) |
|---|
| Code Information |
All codes |
Recalling Firm/
Manufacturer |
FHC, Inc.
9 Main St
Bowdoinham ME 04008-4418
|
| For Additional Information Contact | Keri Seitz
207-666-8190 |
|---|
Manufacturer Reason
for Recall | Potential for non-sterile pin to contaminate sterile field |
|---|
FDA Determined
Cause 2 | 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 |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = HAW
|
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