Biomet, Inc.: (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126

Recall number

Z-1043-2023

Recalling firm

Biomet, Inc.

Product

(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126

Status

Open, Classified

Initiated

2022-12-29

Posted

2023-01-30

Terminated

not on file

Reason

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

Root cause

Labeling Change Control

Action

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.

Quantity

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, IN, MD, OH, PA, WI

Lot, serial or model codes

(1) UDI: (01)00880304270862(17)320504(10)J7186089 Lot Number: J7186089. Expanded Recall: (2)UDI: (01)00880304270879(17)320504(10)J7173870 Lot Number: J7173870. (3) UDI: (01)00880304270893(17)320504(10)J7192119; (01)00880304270893(17)320504(10)J7197508; (01)00880304270893(17)320504(10)J7209606; (01)00880304270893(17)320504(10)J7220427; Lot Numbers: J7192119, J7197508, J7209606, J7220427

510(k) numbers

["K113550"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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