Zimmer Recalls Mislabelled Shoulder Trial Stem Devices
Zimmer, Inc. is removing one lot of Bigliani/Flatow Humeral Provisional Stems because 14mm devices were incorrectly etched and packaged as 12mm.
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, but the source text describes a labeling/etching error without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (Item 00-4301-012-17, lot 62283991). The firm identified that the stems manufactured under this lot are 14mm x 170mm devices that were incorrectly etched and packaged as 12mm x 170mm devices.
This reusable trial device is used in orthopaedic joint replacement surgery for the shoulder. The recall covers nationwide distribution, including Illinois and Missouri.
The FDA has classified this recall as Class II. No specific instructions for consumers are provided in the source text, as this is a medical device used in a clinical setting.
The recalled product
- Product
- Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1
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 (2)
- Item 00-4301-012-17
- lot 62283991
Distribution
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