Recall Z-2588-2011 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Kinamed Inc
Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.
| Date | Jun 17, 2011 (initiated Aug 18, 2010) |
| Status | Terminated |
| Reason | The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening. |
| Root cause | Nonconforming Material/Component |
| Action | 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 custo |
| Quantity | 8 units |
| Distribution | Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM Kinamed, Inc., Nov 9, 2007 |