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.
What this means for you
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 an
- 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.
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02