Reported Jun 20, 2018 · Terminated
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Zimmer 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: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
- Lot codes and dates
15 of 15 products
Products covered by this recall # Barcodes Product as published 1 00880304673885(01)00880304673885(17)230222(10)120150, Lot Number: 120150 2 00880304673885UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700 3 00880304673885UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480 4 00880304673885UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730 5 00880304673885UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370 6 00880304673885UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750 7 00880304673885UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970 8 00880304673885UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680 9 00880304673885UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370 10 00880304673885UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470 11 00880304673885UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060 12 00880304673885UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330 13 00880304673885UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220 14 00880304673885UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080 15 00880304673885UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290 - Amount recalled
- 169
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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