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U.S. Department of Health and Human Services

Class 2 Device Recall SuperCable ScrewDriver, 3.5mm Hex

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 Class 2 Device Recall SuperCable ScrewDriver, 3.5mm Hexsee related information
Date Initiated by FirmAugust 18, 2010
Date PostedJune 17, 2011
Recall Status1 Terminated 3 on October 25, 2011
Recall NumberZ-2588-2011
Recall Event ID 58808
510(K)NumberK072250 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductKinamed 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.
Code Information Lot Numbers K12899 (2pcs) & K12985 (3pcs)
FEI Number 2027148
Recalling Firm/
Manufacturer		 Kinamed Inc
820 Flynn Rd
Camarillo CA 93012
For Additional Information ContactAnthony V. Rose
805-384-2748 Ext. 204
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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
Quantity in Commerce8 units
DistributionWorldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KTT
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