Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is u
FDA device recall Z-2722-2011 · posted 2011-07-06 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 134 devices
- Distribution
- 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.
- Date initiated
- 2011-05-20
- Date posted
- 2011-07-06
- Date terminated
- 2011-10-07
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES (K100845) | Zimmer Spine, Inc. | 2010-09-21 |