FDA Recall Terminated

Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5

Recall: Z-1115-2017 · Initiated January 4, 2017

Recall

Recall Number: Z-1115-2017
Event Number: 75973
Firm: Zimmer Biomet, Inc.
FEI Number: 1825034
Product Code: JWH
Status: Terminated
Root Cause: Process change control
Initiated: January 4, 2017
Terminated: June 11, 2018
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.

Action

On 1/4/2017 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and hospital Risk Managers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: 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 a. Return a digital copy to [email protected] within three (3) days. 4. 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 within 2 weeks (January 20, 2017). a. Request a Return Authorization Number via email to [email protected]. Be sure to specify RECALL as the RGA type. 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. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet or were consigned products will be sent a copy of the Risk Manager Recall Notice directly. It is important that you review the list of hospitals included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals from which you removed affected product. This form will be used to notify each account. If there are no addit

Distribution

NATIONWIDE US ARGENTINA AUSTRALIA AUSTRIA BRAZIL CANADA CHILE CHINA COSTA RICA ECUADOR GREECE INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO NETHERLANDS PANAMA POLAND SINGAPORE THAILAND

Quantity

15,000