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

Humeral Guide Wire Ball Tip Diameter Length recalled by Zimmer Biomet

Zimmer Biomet is recalling Humeral Guide Wire Ball Tip Diameter Length, 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: 63738593 63738594 63738595 63738596 63748395 63748396 63748397 63748398 63753767 63753768 63758425 63758428 63771163 77006530 77006531 77006532 77006533 77006534 77006535 77006536 77006537 77006538 77006539 77006540 77006541 77006542 77006543 77006544 77006545

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-1466-2018
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

Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00

Where it was distributed

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

Nationwide

Questions about this recall

Is Humeral Guide Wire Ball Tip Diameter Length recalled?

Yes. Zimmer Biomet recalled Humeral Guide Wire Ball Tip Diameter Length on 26 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1466-2018.

Why was it recalled?

Potential failure of sterile packaging seal.

Which lots are affected?

Lot Numbers: 63738593 63738594 63738595 63738596 63748395 63748396 63748397 63748398 63753767 63753768 63758425 63758428 63771163 77006530 77006531 77006532 77006533 77006534 77006535 77006536 77006537 77006538 77006539 77006540 77006541 77006542 77006543 77006544 77006545

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 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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