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

Smooth Guide Wire Bullet Tip Diameter Length recalled by Zimmer Biomet

Zimmer Biomet is recalling Smooth Guide Wire Bullet 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: 63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537

Quantity recalled19,483 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-1473-2018
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

Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01

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 Smooth Guide Wire Bullet Tip Diameter Length recalled?

Yes. Zimmer Biomet recalled Smooth Guide Wire Bullet Tip Diameter Length on 26 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1473-2018.

Why was it recalled?

Potential failure of sterile packaging seal.

Which lots are affected?

Lot Numbers: 63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537

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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