Reported Jun 21, 2017 · Terminated

VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

    • VERSA-FXII SC TUBE PLT 90DX16H
    • 95DX16H
    • 95DX18H
    • 95DX20H
    • 95DX22H
Lot codes and dates
  • I10KK954555
  • K150818 Item Numbers
    • 00119309016
    • 00119309516
    • 00119309518
    • 00119309520
    • 00119309522
  • Lot Numbers
    • 60746132
    • 60746132R
    • 60699481
    • 60699481R
    • 60812398
    • 60812398R
    • 60844072
    • 60844072R
    • 60820576
    • 60868450
    • 368893
    • 368898
    • 368898R
    • 368917
    • 368916
    • 368899
    • 61577082
    • 61989416
    • 370907
    • 61895937
    • 61895939
    • 371034
    • 62279718
    • 62351559
    • 62445941
    • 62445942
    • 62511278
    • 62539606
    • 37214360
    • 37214354
    • 37214361
    • 37109128
    • 37109081
    • 62931489
    • 62931529
    • 62930529
    • 63009490
    • 63079560
    • 63564928
    • 63594628
Amount recalled
445

This recall covers 43 products

The agency filed one notice per product. You are reading one of them; the other 42 are below.

30 more are in the archive.

Where it was sold

Why it was recalled

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Zimmer Biomet, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 15, 2019 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.