PathFinder NXT Pivoting Percutaneous Rod Holder This recall
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting…
Why was PathFinder NXT Pivoting Percutaneous Rod Holder This recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number 3564-1; all lots
- Product
- PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 77 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
- Recall date
- July 11, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)