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.
FDA Recall Z-2588-2011 · Posted 2011-06-17
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Recalling FirmKinamed Inc
Recall StatusTerminated
Product CodeKTT
Date Initiated2010-08-18
Date Terminated2011-10-25
Product Quantity8 units
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.
Firm 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 customers.
If you have any questions, please contact (303)-681-2208, (805) 384-2748 or
(800) 827-5775
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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