| Class 2 Device Recall component of NeuroPort Array brain monitoring device. | |
Date Initiated by Firm | March 26, 2010 |
Date Posted | May 20, 2010 |
Recall Status1 |
Terminated 3 on May 25, 2010 |
Recall Number | Z-1619-2010 |
Recall Event ID |
55304 |
510(K)Number | K042384 |
Product Classification |
amplifier, physiological signal - Product Code GWL
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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. |
Code Information |
Serial # 4273-0001 through 4273-0061 |
Recalling Firm/ Manufacturer |
I2s Micro Implantable Systems Llc 391 Chipeta Way Ste G Salt Lake City UT 84108-1264
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For Additional Information Contact | 801-582-5533 Ext. 235 |
Manufacturer Reason for Recall | Component of cranial array may not allow sufficient tightening to maintain inserter position. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 22 units |
Distribution | Nationwide distribution: CA, MA, NY, RI, and UT. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GWL
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