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.
FDA Recall Z-1619-2010 · Posted 2010-05-20
Recalling FirmI2s Micro Implantable Systems Llc
Recall StatusTerminated
Product CodeGWL
Date Initiated2010-03-26
Date Terminated2010-05-25
Product Quantity22 units
Reason for Recall
Component of cranial array may not allow sufficient tightening to maintain inserter position.
Firm Action
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 [email protected], 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.
Root Cause
Device Design
Distribution Pattern
Nationwide distribution: CA, MA, NY, RI, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.