Recall Z-0072-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2013-08-30, terminated 2014-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: CoCr Head (Not distributed in the United States) Used in total hip replacement.. Reason: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-30
- Terminated
- 2014-09-25
- Firm location
- Warsaw, IN, United States
Product description
CoCr Head (Not distributed in the United States) Used in total hip replacement.
Reason for recall
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.