The Recall Desk
ModerateFDA (Devices)·Z-0338-2020·Announced 2019-11-13

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.

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 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
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 →