Zimmer Biomet Recalls Natural-Knee II Femoral Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 13,483 Natural-Knee II femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
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 packaging defect (bag adhesion) without reporting any injuries, illnesses, or deaths. Per the rubric, this fits the 'Moderate' category for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,483 units of the Natural-Knee II (NKII) CSTI Porous Femoral and NKII NP Femoral prostheses. These are knee replacement implants indicated for use in skeletally mature individuals with specific joint diseases. The recall covers various sizes of these semi-constrained, cemented, polymer/metal/polymer components.
The recall was initiated because the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This packaging defect is the specific reason for the recall action. The affected products were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Canada, and many others.
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected implants. Patients who have already had these implants placed should contact their healthcare provider for guidance. The recall number is Z-0839-2016.
The recalled product
- Product
- NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 13,483
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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.
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