Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.
This recall has been terminated (originally issued May 20, 2010).
- Recall Initiated
- March 26, 2010
- Posted
- May 20, 2010
- Terminated
- May 25, 2010
- Recall Number
- Z-1619-2010
- Quantity
- 22 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Component of cranial array may not allow sufficient tightening to maintain inserter position.
Distribution
Nationwide distribution: CA, MA, NY, RI, and UT.
Lot / Code Info
Serial # 4273-0001 through 4273-0061
Root Cause
Device Design
Action Taken
The firm, Blackrock Microsystems, sent a "RECALL" letter dated March 26, 2010, to all customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of all affected devices and promptly return any inventory, perform a physical account of your inventory for the recalled product and email a list of all serial numbers to Andrew Gotshalk at agotshalk@blackrockmicro.com, and to please email Andrew Gotshalk even if you do not have any inserter wand holders or have destroyed or removed from use the inserter wand holders. Blackrock will rework or replace all Inserter Wand Holders that is returned under this recall. If you have any questions regarding this recall please call 801-582-5533 x 275.