Z-2820-2015 Class II Terminated
FDA device recall Z-2820-2015 was initiated by Zimmer, Inc. on Aug 27, 2015 and is designated Class II. 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… The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 112,568 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2015
- Initiation Date
- Aug 27, 2015
- Termination Date
- Mar 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112,568 units
Product Description
Reason for Recall
Distribution Pattern
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2820-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026