Zimmer Guide Wires for orthopedic procedures.
Reported: October 7, 2015 Initiated: August 27, 2015 #Z-2820-2015
Product Description
Zimmer Guide Wires for orthopedic procedures.
Reason for Recall
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 112,568 units
- Distribution
- Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Zimmer Guide Wires for orthopedic procedures.. Recalled by Zimmer, Inc.. Units affected: 112,568 units.
Why was this product recalled? ▼
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2015. Severity: Moderate. Recall number: Z-2820-2015.
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