Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error
Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.
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 where the product itself is correctly identified, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Zimmer Biomet, Inc. is recalling the RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828, lot number 856550. The recall is due to a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and the actual product are correctly identified, but the internal patient label could be incorrect.
The affected product was distributed nationwide in the United States and internationally in Argentina, the Netherlands, and Canada. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should verify the product identification against the outer box label and the actual product to ensure the correct implant is used. If the internal patient label is found to be incorrect, the product should not be used until the discrepancy is resolved.
The recalled product
- Product
- RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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)
- Lot Number: 856550
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Zimmer Biomet, Inc. 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.
See all 10 products in this recall →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