Z-2588-2011

Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is...

Name: Z-2588-2011 Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is...
Creator: Kinamed Inc
Published: 2010-08-18
License: https://open.fda.gov/license/

Kinamed Inc / initiated 2010-08-18 / Terminated / root cause: manufacturing process

FDA source

Kinamed Inc began a recall of 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... on 2010-08-18. The reason FDA records is "The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2588-2011
Status: Terminated
Initiated: 2010-08-18
Posted: 2011-06-17
Terminated: 2011-10-25
Recalling firm: Kinamed Inc
Product: 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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: manufacturing process
FDA 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 customers. If you have any questions, please contact (303)-681-2208, (805) 384-2748 or (800) 827-5775
Quantity in commerce: 8 units
Distribution: Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
Product codes and lots: Lot Numbers K12899 (2pcs) & K12985 (3pcs)

Product code KTT

K072250Class IISupercable Grip and Plate SystemKinamed, Inc. / cleared 2007-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)