Recall Z-2820-2015 ยท FZX Guide, Surgical, Instrument
Zimmer, Inc.
Zimmer Guide Wires for orthopedic procedures.
| Date | Sep 30, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Package design/selection |
| Action | Zimmer sent an "URGENT MEDICAL DEVICE RECALL" notifications dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities: 1.Review the notification and ensure affected personnel are aware of the contents. 2.Locate part number and lot number combinations listed in attachment 1 and quarantine the devices immediately. 3.Carry out a physical count of all affected product in your territory, including hospitals in your territory with direct sales as well as consignment, and complete the I |
| Quantity | 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.