Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics N
FDA device recall Z-1619-2010 · posted 2010-05-20 · Terminated
Recall details
- Recalling firm
- I2s Micro Implantable Systems Llc
- Reason for recall
- Component of cranial array may not allow sufficient tightening to maintain inserter position.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GWL
- Quantity affected
- 22 units
- Distribution
- Nationwide distribution: CA, MA, NY, RI, and UT.
- Date initiated
- 2010-03-26
- Date posted
- 2010-05-20
- Date terminated
- 2010-05-25
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM (K042384) | Cyberkinetics, Inc. (Cki) | 2005-03-29 |