Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling
Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving surgical implant components with labeling errors. While there are no reported injuries or adverse events, the defect poses a risk of surgical error if incorrect sizes or sides are used during knee replacement procedures.
Plain-English summary
Biomet, Inc. is recalling specific Vanguard Knee System PS Open Box Femoral components intended for knee joint replacement. These components measure 57.5 mm, 60 mm, and 62.5 mm and are incorrectly labeled.
The labels on the components indicate either a different size or different side (left versus right) than the actual component. This discrepancy could lead to incorrect component selection during knee replacement surgery.
A total of 91 affected units were distributed internationally to Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. In the United States, they were distributed to Florida, Indiana, Maryland, Ohio, Pennsylvania, and Wisconsin.
Patients and healthcare providers should contact Biomet, Inc. for information about this recall and any necessary replacement or verification procedures for their components.
The recalled product
- Product
- (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral…
- Manufacturer
- Biomet, Inc.
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- (01)00880304270893(17)320504(10)J7197508
- (01)00880304270893(17)320504(10)J7209606
- (01)00880304270893(17)320504(10)J7220427
- Lot Numbers: J7192119
- J7197508
- J7209606
- J7220427
Distribution
Part of a larger recall action
This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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