Biomet, Inc.: Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee Syste

Is my product affected?

Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 1

• UPC 00880304438262
• UPC 00880304476714
• UPC 00880304438354

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

What happened

Biomet, Inc. is recalling 93 units of Vanguard Knee System tibial bearing components due to the potential presence of elevated endotoxin levels that exceed specification limits. The affected products were distributed worldwide, including throughout the United States and in Canada, India, Japan, Mexico, Thailand, Taiwan, Singapore, and numerous other countries. The recalled products include specific lot numbers of PS+ Tibial Bearing (12 MM and 14 MM sizes) and PS Tibial Bearing E1 Infused (18 MM X 59 MM) components, identifiable by their UDI numbers and lot codes.

The recall record does not specify a remedy or recommended action for consumers who may have received these products.

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: 93 units Lot/code info: Lot Numbers: UDI Number 294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130 509970 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970 509990 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990 175980 Knees Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM (01)00880304438354(17)220114(10)175980 294130R Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130R 509970R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970R 509990R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in 2020-04-17
• Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.2020-04-17
• 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
• Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis2020-04-17
• 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