CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

M/DN Intramedullary Fixation Humeral Guide Wire recalled

Zimmer Biomet is recalling M/DN Intramedullary Fixation Humeral Guide Wire - Smooth Diameter Length Single Use Only, distributed nationwide in the US. The recall was initiated on 26 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

Quantity recalled19483 total products

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1465-2018
FDA event ID: 79681
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2018
FDA classified: 20 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

26 Mar 2018	Recall initiated by company
20 Apr 2018	Classified by FDA	+25 days
2 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential failure of sterile packaging seal.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Where it was distributed

US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Nationwide

Questions about this recall

Why was it recalled?

Potential failure of sterile packaging seal.

Which lots are affected?

Lot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

Where was it sold?

US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 79681

This product is part of a recall event; the main page for the event is M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip recalled.

Reported	Class	Recall	Company	Reason	Where
2 May 2018	CLASS II	M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Humeral Guide Wire Ball Tip Diameter Length recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Pressure Sentinel Intramedullary Reaming System Guide Wire recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Zimmer Natural Nail System Tear Drop Guide Wire Diameter Length recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	ZMS Intramedullary Fixation Smooth Guide Wire Diameter Length recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Smooth Guide Wire Bullet Tip Diameter Length recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	ZMS Intramedullary Fixation Smooth Guide Wire Diameter Length recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Zimmer Natural Nail System Tear Drop Guide Wire Diameter Length recalled	Zimmer Biomet	Sterility	Nationwide
2 May 2018	CLASS II	Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled	Zimmer Biomet	Sterility	Nationwide

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