Series II Tibial Bear Insert Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.
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 recall involving potential material degradation in an orthopedic implant. No illnesses or injuries have been reported. The hazard is theoretical—material properties may be affected by oxidation, but actual component failures have not been documented.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert (Part Number 3052-0515), a component used in knee replacement surgeries.
The recalled components were manufactured using UHMWPE (ultra-high molecular weight polyethylene) raw material that is over 5 years of age. This aged raw material has the potential to develop elevated levels of oxidation. Oxidation within UHMWPE can impact the material's properties and functionality.
The affected components have been distributed nationwide in the United States and internationally. The recalled lot number is WK4PX0. Patients who received this component should consult with their surgeon or healthcare provider regarding potential risks and appropriate monitoring or management options.
The recalled product
- Product
- SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
- Manufacturer
- Howmedica Osteonics Corp.
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 (1)
- GTIN: 07613327034042 Lot Numbers: WK4PX0
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. 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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