Z-1619-2010

Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or /...

Name: Z-1619-2010 Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or /...
Creator: I2s Micro Implantable Systems Llc
Published: 2010-03-26
License: https://open.fda.gov/license/

Blackrock Microsystems / initiated 2010-03-26 / Terminated / root cause: design

FDA source

I2s Micro Implantable Systems Llc began a recall of Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake... on 2010-03-26. The reason FDA records is "Component of cranial array may not allow sufficient tightening to maintain inserter position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1619-2010
Status: Terminated
Initiated: 2010-03-26
Posted: 2010-05-20
Terminated: 2010-05-25
Recalling firm: Blackrock Microsystems
Product: 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.
Product code: GWL Amplifier, Physiological Signal
Reason for recall: Component of cranial array may not allow sufficient tightening to maintain inserter position.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 22 units
Distribution: Nationwide distribution: CA, MA, NY, RI, and UT.
Product codes and lots: Serial # 4273-0001 through 4273-0061

Product code GWL

K042384Class IINeuroport Recording Microelectrode Array SystemCyberkinetics, Inc. (Cki) / cleared 2005-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)