Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, R
FDA device recall Z-1981-2012 · posted 2012-07-10 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
- Action taken
- Zimmer sent an Urgent Medical Device Correction and Removal notification dated June 5, 2012 to distributors and all affected accounts of Zimmer Spine. The notice identified the affected products, problem and actions to be taken. Distributors were asked to hand deliver Recall Notices to Surgeons and return the completed Surgeon Contact Certification Form within 10 working days to ronald.musselman@zimmer.com or FAX to 1-512-258-0995. Notices to Surgeons and User facilities included revised directions/precautions for the Instructions for Use and attached Surgical Techique. Devices will be removed once newly design parts become available. For any related questions or assistance about this please contact Zimmer Spine Customer Service at 866-774-6368.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 249 ( angle handle and straight) in total
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
- Date initiated
- 2012-06-05
- Date posted
- 2012-07-10
- Date terminated
- 2014-09-03
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES (K100845) | Zimmer Spine, Inc. | 2010-09-21 |