Class 2 Device Recall Torque Limiting Handle

• Date Initiated by Firm: October 04, 2005
• Date Posted: November 23, 2005
• Recall Status: Terminated on February 21, 2007
• Recall Number: Z-0183-06
• Recall Event ID: 33713
• 510(K)Number: K041592
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
• Code Information: The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
• FEI Number: 3002498892
• Recalling Firm/ Manufacturer: Theken Spine LLC; 283 E Waterloo Rd; Akron OH 44319-1238
• For Additional Information Contact: Mr. Ron P. Clough; 330-773-7677
• Manufacturer Reason for Recall: The torque value of the device may increase over time. The increase could exceed the tolerance specification.
• FDA Determined Cause: Other
• Action: The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.
• Quantity in Commerce: 71
• Distribution: The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = LXH