Zimmer Biomet Recalls Mislabelled Tibial Nail Due to Size Discrepancy
Zimmer Biomet is recalling a specific lot of 8.3mm tibial nails that are actually 12mm. The product was distributed only in the Netherlands.
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 (size discrepancy) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008. The recall is due to a labeling error where the item is labeled as an 8.3mm, but it is actually a 12 mm. The product is intended for temporary fracture fixation and stabilization of the bone in the tibia.
The affected product was not distributed in the United States. It was distributed in the Netherlands. The specific lot number is 61169228R, and the UDI is (01)00889024097551(17)190228(10)61169228R.
This recall is classified as Class II by the FDA. Consumers or healthcare providers in the Netherlands should check their inventory for this specific model and lot number. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound…
- Manufacturer
- Zimmer Biomet, 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)
- UDI: (01)00889024097551(17)190228(10)61169228R
- Lot 61169228R
Distribution
Distribution scope not specified by the agency.
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