Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be use
FDA device recall Z-2588-2011 · posted 2011-06-17 · Terminated
Recall details
- Recalling firm
- Kinamed Inc
- Reason for recall
- The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening.
- Action taken
- The firm, Kinamed Inc., sent a recall letter dated August 18, 2010 to consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The customers were instructed to Immediately examine their stock and return any Kinamed SuperCable Screwdriver, 3.5mm Hex bearing these lot numbers, along with the completed attached Effectiveness Check Form and shipment under RMA #74567 to the attention of: "Director of Quality Assurance" Kinamed, Inc. 820 Flynn Road Carnarillo, CA 93012-8701 Note: The Kinamed sales agent shipped and had the product replaced for the customers. If you have any questions, please contact (303)-681-2208, (805) 384-2748 or (800) 827-5775
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 8 units
- Distribution
- Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
- Date initiated
- 2010-08-18
- Date posted
- 2011-06-17
- Date terminated
- 2011-10-25
- Location
- Camarillo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUPERCABLE GRIP AND PLATE SYSTEM (K072250) | Kinamed, Inc. | 2007-11-09 |