Recall Z-0411-2016— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-11-24, terminated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.. Reason: Complaints that the ratchet teeth of the tube are not latching onto the rod..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-24
- Terminated
- 2017-03-24
- Firm location
- Warsaw, IN, United States
Product description
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
Reason for recall
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Data sourced from openFDA. This site is unofficial and independent of the FDA.