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

Bead Tip Gd Wire recalled by Zimmer Biomet

Zimmer Biomet is recalling Bead Tip Gd Wire, 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 codes563080 563090 407870 408160 408140 412690 412750 412720 412740 668840 202750 389030 410170 410180 395170 513920 201790 232930 639560 800410 980930 134560 271820 351760 504870 578400 605700 750960 750970 913730 921150 058010 631570 969080 101380 944200 969090 203000 449730 449740 449750 449720 665510 820130 850170 978340 221240 419010 848820 848810 278720 387620 437340 502200 623450 038560 186020 212630 183170 183180 183190 434630 183200 930950 693480

Quantity recalled2168

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-2239-2018
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

BEAD TIP GD WIRE 3.0MM X 60CM; 29402 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

Is Bead Tip Gd Wire recalled?

Yes. Zimmer Biomet recalled Bead Tip Gd Wire on 16 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2239-2018.

Why was it recalled?

Which lots are affected?

563080 563090 407870 408160 408140 412690 412750 412720 412740 668840 202750 389030 410170 410180 395170 513920 201790 232930 639560 800410 980930 134560 271820 351760 504870 578400 605700 750960 750970 913730 921150 058010 631570 969080 101380 944200 969090 203000 449730 449740 449750 449720 665510 820130 850170 978340 221240 419010 848820 848810 278720 387620 437340 502200 623450 038560 186020 212630 183170 183180 183190 434630 183200 930950 693480

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

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