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

Z Nail Pf Univ Z Nail Gt R Z Nail Gt L Z Nail Tibia Univ Z recalled

Zimmer Biomet is recalling Z Nail Pf Univ Z Nail Gt R Z Nail Gt L Z Nail Tibia Univ Z Nail Tibia Univ Z Nail Tibia, 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 codes510K:K083497, K082770 Item Numbers: 47249146014 47249246014 47249246114 47249538014 47249540014 47249542014 47249544014 Lot Numbers: 61103290 61103290V 61138671 61138682 61138671V 61138682V 61138676 61138687 61138676V 61138687V 61103287 61103287V 61103281 61103283 61103281V 61103283R 61103283V 61180209 112352 61202807 61205842 61202807R 61205842R 61202808 61202808R 61205846 61187350 61187350R 61218276 61218276R 61216615 61223061 61230526 61229396 61229407 61229396R 61229407R 61245120 61245155 61260972 112919 61237017 61263494 61260970 61260970R 61256429 61273711 61187351 61273717 61277263 61187351R 61279018 61289441 61277247 61283862 61283873 112952 112774 61301593 61306420 61301600 61318941 61318947 61314858 61318980 61326405 61326398 61330162 61326398R 61328635 61332013 61328635R 61332013R 61332010 61338025 61353225 61358628 61338029 61358630 61358666 61371216 61370312 61370393 61363474 61363484 61314868 61391745 61471261 61471280 61477302 61550757 7891217 61889853 63246520

Quantity recalled1707

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-2599-2017
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

Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

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?

510K:K083497, K082770 Item Numbers: 47249146014 47249246014 47249246114 47249538014 47249540014 47249542014 47249544014 Lot Numbers: 61103290 61103290V 61138671 61138682 61138671V 61138682V 61138676 61138687 61138676V 61138687V 61103287 61103287V 61103281 61103283 61103281V 61103283R 61103283V 61180209 112352 61202807 61205842 61202807R 61205842R 61202808 61202808R 61205846 61187350 61187350R 61218276 61218276R 61216615 61223061 61230526 61229396 61229407 61229396R 61229407R 61245120 61245155 61260972 112919 61237017 61263494 61260970 61260970R 61256429 61273711 61187351 61273717 61277263 61187351R 61279018 61289441 61277247 61283862 61283873 112952 112774 61301593 61306420 61301600 61318941 61318947 61314858 61318980 61326405 61326398 61330162 61326398R 61328635 61332013 61328635R 61332013R 61332010 61338025 61353225 61358628 61338029 61358630 61358666 61371216 61370312 61370393 61363474 61363484 61314868 61391745 61471261 61471280 61477302 61550757 7891217 61889853 63246520

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

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide