Z-1042-2023Class II

(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses...

Name: Z-1042-2023 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses...
Creator: Biomet, Inc.
Published: 2022-12-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-12-29 / Open, Classified / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS... on 2022-12-29. FDA classified it as Class II and gives the reason as "Components Incorrectly labeled as either smaller or larger and incorrect side (right/left)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1042-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-29
Posted: 2023-01-30
Recalling firm: Zimmer GmbH
Product: (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Root cause tag: labeling and UDI
FDA 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 [email protected], 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 [email protected]. ______________________________________________________________________ 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 in commerce: 157 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
Product codes and lots: (1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1042-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1042-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-1043-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30

Product code JWH

K113550Class IIVanguard Complete Knee SystemBiomet Manufacturing Corp / cleared 2012-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)