ECHO POR FMRL NC 9X125, model # 192009
Recall
- Recall Number
- Z-0300-2018
- Event Number
- 78167
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- KWA
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- June 5, 2017
- Terminated
- March 6, 2018
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
ECHO POR FMRL NC 9X125, model # 192009
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to [email protected] and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form and return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Recall Return Authorization Number via SMS or via email to [email protected] (domestic) or via email to [email protected] (international). b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5
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