Agency classClass IIOur severity:High FDA (Devices)·Z-1470-2018·Announced 2018-05-02

Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires

Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a potential sterile packaging failure.

Plain-English summary

Zimmer Biomet, Inc. is recalling ZMS Intramedullary Fixation Smooth Guide Wires (3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00) because of a potential failure of the sterile packaging seal. The recall involves 19,483 units distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad.

The affected products are identified by the following lot numbers: 63662549, 63668704, 63696974, 63709171, 63721377, 63731176, 63764550, 63771164, 63781920, 63803595, 63812302, 63817719, and 63826242. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the specific item number and lot numbers listed above. If the affected products are found, they should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.

The recalled product

Product: ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Instrument
Hazard: sterile-packaging-failure
Affected units: 19,483

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · sterile packaging failure