Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies
Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to surgical delays or revision surgery, fitting the criteria for moderate severity without reported fatalities or immediate serious injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the Orthopedic Salvage System (OSS) 9cm prosthesis, specifically the Knee System Tibial Bodies. The recall is due to a labeling error where specific lots of the Standard OSS Modular Proximal Tibia are incorrectly identified as AVL Modular Proximal Tibia components.
The mislabeling poses potential risks to patients, including a delay in surgery of less than 30 minutes or the need for a revision surgery, which carries an increased risk of infection. The affected units were distributed to facilities in Wisconsin, New Jersey, California, Maryland, Washington, Louisiana, Massachusetts, and Texas.
Healthcare providers and patients should verify the labeling of their components against the specific part and lot numbers provided in the recall notice. If the components match the recalled items, they should contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 16
Distribution
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