—#99671

Product

Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.

FDA product code: HXX — Screwdriver
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K100845
Affected lot / code info: REF 3566-1 Lots 62TP, 63SG, 65DE, 66CH.

Why it was recalled

Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and final locking of Closure Tops during the screw and rod construct assembly of the Pathfinder NXT Pedicle Screw System. When the hex tip of the Closure Top Driver is

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer, Inc. issued an "URGENT MEDICAL DEVICE RECALL" letters dated April 2011, to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed that (THE GOLD CLOSURE TOP DRIVERS 3566-1 and 3566-2 ARE NOT TO BE USED FOR FINAL TIGHTENING); an alternate instrument for final construct tightening will be included in the instrument set 3570-1 short and 3570-2 long (These instruments are silver instead of gold for easy identification and do not include a retention feature for holding the Closure Top); to ensure final drivers are added to each PathFinder NXT set and inspect Closure Top Drivers for rounded hex wear; contact their customer service representative if they do not have both versions; and complete and return all attached forms via fax to: Zimmer Spine at 512-258-0995. The letter states that the firm will revise the surgical technique to show the updated uses of the screwdrivers. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.

Timeline

Recall initiated: 2011-05-20
Posted by FDA: 2011-07-06
Terminated: 2011-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99671. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.