Biomet, Inc.: Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis

Is my product affected?

Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis

• UPC 00880304431638
• UPC 00880304431317

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling 91 units of Vanguard Knee System knee prostheses due to the potential presence of elevated endotoxin levels that exceed specification limits. The affected products are the Series-A Standard Patella in 28 MM and 31 MM sizes, distributed worldwide including throughout the United States and to Canada, India, Japan, Thailand, Singapore, Taiwan, the Netherlands, Mexico, and several other countries. The recalled units are identified by two lot numbers: UDI Number 508390 for the 28 MM patella (with expiration date 12/18/2021) and UDI Number 309810 for the 31 MM patella (with expiration date 12/28/2021).

The recall record does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of elevated endotoxin levels that exceed the specification limit

Details from the source

Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL. Quantity: 91 units Lot/code info: Lot Numbers: UDI Number 508390 Vanguard Knee System, Series-A Standard Patella, 28 MM (01)00880304431638(17)211218(10)508390; 309810 Vanguard Knee System, Series-A Standard Patella, 31 MM (01)00880304431317(17)211228(10)309810

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis2020-04-17
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• Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee 2020-04-17

All FDA (Device enforcement) recalls