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)
This recall has been terminated (originally issued June 16, 2005).
- Company
- Fhc, Inc.
- Recall Initiated
- March 14, 2005
- Posted
- June 16, 2005
- Terminated
- July 8, 2008
- Recall Number
- Z-0895-05
- Quantity
- 169 units
- Firm Location
- Bowdoinham, ME
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for non-sterile pin to contaminate sterile field
Distribution
Natiowide
Lot / Code Info
All codes
Root Cause
Other
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.
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