Reported Feb 8, 2023 · Ongoing

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

Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

5 of 5 products

Products covered by this recall
Model / numberProduct as published
183104(2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm
183106(3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm
183108(4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm
183110(5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm
183112
Lot codes and dates

3 of 3 products

Products covered by this recall
#BarcodesProduct as published
1008803042707700088030427077000880304270770008803042707700088030427077000880304270787(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
20088030427078700880304270794J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881
30088030427008000880304270817(4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.
Amount recalled
157 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.