CoCr Head (Not distributed in the United States) Used in total hip replacement.
Reported: November 6, 2013 Initiated: August 30, 2013 #Z-0072-2014
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 604064 total
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
CoCr Head (Not distributed in the United States) Used in total hip replacement.. Recalled by Zimmer, Inc.. Units affected: 604064 total.
Why was this product recalled? ▼
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0072-2014.
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