Agency classClass IIOur severity:High FDA (Devices)·Z-1465-2018·Announced 2018-05-02

Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure

Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

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 and involves a potential sterile packaging failure, which poses a risk of infection (a high-risk hazard) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 19,483 units of the M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only (Item Number: 00-2255-025-00). The recall is due to a potential failure of the sterile packaging seal. The affected lots are 63733049, 63738623, 63748399, 63753770, 63758430, 63849380, 77006555, 77006556, and 77006557.

The products were distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed. Patients who have already received these devices should contact their healthcare provider for further instructions.

The recalled product

Product: M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Instrument
Hazard: sterility-compromise
infection-risk
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.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · sterility compromise