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R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG,...

FDA Device Recall #Z-2595-2017 — Class II — April 28, 2017

Recall Summary

Recall Number Z-2595-2017
Classification Class II — Moderate risk
Date Initiated April 28, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 3856

Product Description

R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

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.

Distribution Pattern

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

Lot / Code Information

510K: K965098,K142281,K962561 Item Numbers: 00224001048 00224001142 00224001144 00224001146 00224001148 00224001246 00224001248 00224001340 00224001342 00224001344 00224001346 00224001348 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 Lot Numbers: 60677568 60684983 60677568R 60684983R 60670026 60670026R 60645750 60645750R 60691655 60691655R 60711471 60711471R 60715081 60715081R 60725139 60725139R 60754804 60754804R 60747476 60747462 60747462R 60747477 60815078 60815079 60816181 60815078R 60815079R 60816181R 60816180 60816180R 60820253 367186 367189 60822094 367186R 367189R 60822094R 367810 367810R 60839006 60837666 60844163 60844196 60837666R 60844163R 60844196R 367869 367871 367869R 60848701 60854080 60848701R 60854080R 60854079 60854079R 367829 367829R 60859062 368307 368310 60859063 368310R 60859063R 368299 368302 368299R 368302R 368148 368143 368294 368294R 368297 368150 368298 368301 368305 368309 368298R 368301R 368309R 368562 367809 368531 368560 368561 368577 368580 368581 367809R 368560R 368581R 368530 368578 368582 368753 368517 368306 368575 368576 368306R 368575R 60919033 60919033R 60919035 60919035R 368340 368559 368340R 368559R 60960629 60960629R 60919039 60919039R 60967107 368149 61133054 61133054R 61140815 61140815R 61140818 61140819 61140818R 61140806 61140806R 61120929 61159207 61159207R 61172912 61175878 61175879 61175878R 61175879R 61143391 61178288 61143391R 61178288R 61172908 61172906 61172907 61172907R 61214457 61220918 61214457R 61220921 61228029 61220921R 61228029R 61206026 61206026R 61234881 61234881R 61244866 61244866R 61244870 61244870R 61266211 61266211R 61281343 61285992 61285992R 61290289 61290287 61290287R 61281344 61290286 61255582 61303822 61255582R 61298515 61294529 61332795 61303827 61303827R 61332793 61313784 61328171 61317759 61328170 61317759R 61328170R 61332794 61341157 61332794R 61338963 61338964 61357281 61357283 61357283R 61357280 61367359 61367361 61382442 61395133 61428549 61428549R 61475214 61475214R 61453190 61453194 61501069 61542230 61556956 61556957 61621133 370537 370519 370528 370588 370601 370602 370600 370676 370668 370682 370681 370677 37107639 62322143 62413175 37108737 37108740 37108731 62430032 45002782 62495894 37107661 37107515 62520406 62523522 62520407 37107521 62533618 37107523 37107657 37211418 37211705 37211951 37212517 37214483 37215822 37215823 37215824 37215825 37216452 37216810 37218034 37218265 37218692 37218874 37218875 37218879 37218880 37218881 37219144 62602659 37214456 37214482 37217395 62577102 37214480 62610838 37214452 62608435 37214457 37214474 37220504 37214475 37220497 37220505 37214464 37212807 37213531 37213532 37213538 37214459 62613231 37213062 37214458 37212168 37220496 37220506 37220507 37214481 37214476 37214484 37211555 37214465 37211249 37213927 37109144 62602670 37109319 37109327 37109329 37109348 37109350 37109332

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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