Recall Z-2543-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-30, terminated 2015-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.. Reason: Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-30
- Terminated
- 2015-03-06
- Firm location
- Warsaw, IN, United States
Product description
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
Reason for recall
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
Data sourced from openFDA. This site is unofficial and independent of the FDA.