CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report

Ball Tip Guide Wire 2.0mmx60cm recalled by Zimmer Biomet

Zimmer Biomet is recalling Ball Tip Guide Wire 2.0mmx60cm, distributed nationwide in the US. The recall was initiated on 16 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes271231

Quantity recalled26

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-2235-2018
FDA event ID: 80193
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2018
FDA classified: 15 Jun 2018
Reported: 27 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

16 May 2018	Recall initiated by company
15 Jun 2018	Classified by FDA	+30 days
27 Jun 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

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

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

BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Where it was distributed

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

271231

Where was it sold?

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

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

12 other products · FDA event 80193

This product is part of a recall event; the main page for the event is G-pin 2.8bl 3.2pl recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
27 Jun 2018	CLASS II	G-pin 2.8bl 3.2pl recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	G-pin 2.8bl 3.2pl recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	COCR THD TIP recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Ball Tip Guide Wire 3.2mmx55cm recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Recon Drill; 14-443023 Intended to be used as a guide pin recalled	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Guide Wire w/ Ball Tip 2.0MMX98CM recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Drill Pt Guide Wire recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Bead Tip Gd Wire recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Drill PT Guide Wire 3.2MMX98CM recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	Ball Tip Guide Wire 3.2mmx98cm recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	COCR THD TIP recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
27 Jun 2018	CLASS II	G-pin 2.8bl 3.2pl recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide

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All 873

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11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

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