CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Versa-fxii Sc Tube Plt 90dx16h, 95dx16h, 95dx18h, 95dx20h, 95dx22h recalled

Zimmer Biomet is recalling Versa-fxii Sc Tube Plt 90dx16h, 95dx16h, 95dx18h, 95dx20h, 95dx22h, distributed in 43 states. The recall was initiated on 28 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesI10K: K954555,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

Quantity recalled445

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-2593-2017
FDA event ID: 77141
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 28 Apr 2017
FDA classified: 15 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

28 Apr 2017	Recall initiated by company
15 Jun 2017	Classified by FDA	+48 days
21 Jun 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

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

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

Where it was distributed

Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below

Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it 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.

Which lots are affected?

I10K: K954555,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

Where was it sold?

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

7 other products · FDA event 77141

This product is part of a recall event; the main page for the event is Fem Im Nail 14mmdx30cm Left recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
21 Jun 2017	CLASS II	Fem Im Nail 14mmdx30cm Left recalled by Zimmer Biomet	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	Z Nail Pf Univ Z Nail Gt R Z Nail Gt L Z Nail Tibia Univ Z recalled	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	Versa-fx Ii Std Tube 130dx16h, 130dx18h, 130dx20h, 135dx16h recalled	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	Fem Im Nail 15mmdx30cm, Fem Im Nail 16mmdx30cm Fem Im Nail recalled	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	Tibial I/m Nail 15mmdx26cm, Tibial I/m Nail 15mmdx28cm recalled	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	4.5 Broad Scp Plt 26-h Ster recalled by Zimmer Biomet	Zimmer Biomet	Sterility	43 states
21 Jun 2017	CLASS II	R-f Im Nail 10mmdx48cm Lg, 11mmdx42cm, 11mmdx44cm recalled	Zimmer Biomet	Sterility	43 states

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