Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage
Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.
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 a Class II medical device recall for a manufacturing defect with no reported injuries or hospitalizations. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Biomet, Inc. is recalling the Vanguard Knee System AS Tibial Bearing / DCM ArCom (Model 189082, Lot Number 65966530). This component is used in knee replacement surgery.
The product is being recalled due to possible damage that may have occurred during the manufacturing process. The FDA has classified this as a Class II recall.
A total of 19 units are affected: 1 in the United States (Indiana) and 18 units distributed outside the US in Canada, India, Netherlands, and Puerto Rico. Patients who received this implant component should contact their healthcare provider or Biomet directly for guidance.
The recalled product
- Product
- Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and…
- Manufacturer
- Biomet, Inc.
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 (3)
- Item Number: 189082
- Lot Number: 65966530
- UDI-DI: (01)00880304436954(17)280413(10)65966530
Distribution
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