Date Initiated by Firm | December 21, 2018 |
Create Date | February 23, 2019 |
Recall Status1 |
Terminated 3 on May 13, 2020 |
Recall Number | Z-0937-2019 |
Recall Event ID |
82004 |
510(K)Number | K040770 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | Vanguard Knee System Series-A Standard Patella sizes 31mm
Item Number: 184764 |
Code Information |
Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory.
Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier.
Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand.
Distributors to return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter.
Hospital risk managers be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
- Assisting the Zimmer Biomet sales representative with the quarantine of the product
- Returning Certificate of Acknowledgement to Zimmer Biomet.
Questions or concerns after reviewing notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday |
Quantity in Commerce | 45 units |
Distribution | MN, VA
Foreign: Korea, New Zealand and Japan |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JWH
|