The Recall Desk
ModerateFDA (Devices)·Z-1948-2019·Announced 2019-07-10

Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues

Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.

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 hazard involves a potential breach of sterile packaging without reported injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling K-Wire Trochar Tips, Model Number 212000008. These disposable instruments are used to facilitate the implantation of orthopedic medical devices in trauma cases. The recall involves 3,022 units distributed nationwide in the United States and in several foreign countries, including Australia, Canada, Chile, Japan, and the Netherlands.

The recall was initiated because there is a potential for weak seals in the sterile packaging. This defect could compromise the sterility of the medical devices. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare providers and consumers should stop using the affected K-Wire Trochar Tips and contact Zimmer Biomet for instructions on how to return or dispose of the products. The recall covers specific lot numbers, which are listed in the official FDA documentation.

The recalled product

Product
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Instruments
Hazard
Affected units
3,022

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · sterility compromise

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