(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number

FDA device recall Z-1043-2023 · posted 2023-01-30 · Open, Classified

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

Action taken

UPDATE: 2/7/23 Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL EXPANSION Letter on 2/07/23 to Distributors, Risk Manager, Surgeons. (An Urgent Medical Device Letter issued to consignees new accounts not previously notified Dec 29, 2022). Letters state reason for recall, health risk and action to take: This is a 14-lot scope expansion to the recall notification initiated on December 29, 2022, for the Vanguard Posterior Stabilized Open Box Femoral components. Letter states reason for recall, health risk and action to take: . Immediately locate and quarantine affected product in your inventory. Return all affected product from your distributorship and from affected hospitals within your territory. . Complete Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have affected products available to return in your territory. . If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Or your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. ______________________________________________________________________ Zimmer Biomet issued Urgent Medical Device Recall via email on December 29, 2022. OUS Distributors notified via email. Hospital risk managers and surgeons, as well as distributors with product notified via courier. Surgeons will be provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions. - Returning Certificate of Acknowledgment to Zimmer Biomet.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

JWH

Quantity affected

91 units

Distribution

International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL,

Date initiated

2022-12-29

Date posted

2023-01-30

Location

Warsaw, IN

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