Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Reported: November 6, 2013 Initiated: August 30, 2013 #Z-0071-2014
Product Description
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
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
- 194 (8770-040)
- 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? ▼
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.. Recalled by Zimmer, Inc.. Units affected: 194 (8770-040).
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-0071-2014.
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