PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intende

FDA device recall Z-1933-2012 · posted 2012-07-03 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we

Action taken

The firm, Zimmer Spine, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the notification and ensure they are aware of the content; to immediately remove and discontinue use of Pivoting Percutaneous Rod Holder (part number 3564-1) from Pathfinder NXT instrument sets in their possession and follow the PathFinder NXT Surgical Technique; to notify their Zimmer Spine customer service representative to obtain return authorization; and return the complete Surgeon Contact Certification Form within 10 working days from receipt of notification to ronald.musselman@zimmer.com or Fax to 1-512-258-0995. If you have any questions, call Zimmer Spine Customer Service at 866-774-6368.

Root cause

Device Design

Status

Terminated

Product code

NKB

Quantity affected

77 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.

Date initiated

2012-06-05

Date posted

2012-07-03

Date terminated

2013-02-14

Location

Warsaw, IN

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