Zimmer Biomet Recalls Cable Buttons for Polyaxial Locking Plates
Zimmer Biomet is recalling cable buttons for NCB Polyaxial Locking Plates because non-highly polished implants may adhere to the packaging bag.
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 the source text describes a packaging-related issue (adherence to bags) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling cable buttons for the NCB Polyaxial Locking Plate, 2.5 mm Hex Drive (Item No. 47223206001). The recall involves 5,459,583 total devices that were distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the device during use.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on return or replacement.
The recalled product
- Product
- cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 5,459,583
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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 41 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 · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateZimmer Recalls NCB Polyaxial Locking Plate System NCB Screws Due to Incorrect Size
FDA (Devices) · 2012-08-22
- ModerateZimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
FDA (Devices) · 2016-01-20
- HighZimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners
FDA (Devices) · 2018-03-21
- HighZimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
FDA (Devices) · 2020-06-10
- ModerateZimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
FDA (Devices) · 2016-03-02
- ModerateZimmer Biomet Recalls Hip Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21