Device product
Zimmer Guide Wires for orthopedic procedures.
Z-2820-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 72132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,568 units
- Official record key
device-enforcement:Z-2820-2015
Official wording
Reason: 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.
Code information: 00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.
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.
Derived failure modes
-
Unknown
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.