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U.S. Department of Health and Human Services

Class 2 Device Recall MDN Nails

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  Class 2 Device Recall MDN Nails see related information
Date Initiated by Firm April 28, 2017
Create Date June 15, 2017
Recall Status1 Terminated 3 on May 15, 2019
Recall Number Z-2597-2017
Recall Event ID 77141
510(K)Number K965098  K142281  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM
TIBIAL I/M NAIL 15MMDX30CM
TIBIAL I/M NAIL 14MMDX32CM
TIBIAL I/M NAIL 15MMDX32CM
TIBIAL I/M NAIL 14MMDX34CM
TIBIAL I/M NAIL 15MMDX34CM
TIBIAL I/M NAIL 14MMDX36CM
TIBIAL I/M NAIL 15MMDX36CM
TIBIAL I/M NAIL 14MMDX38CM
TIBIAL I/M NAIL 15MMDX38CM
TIBIAL I/M NAIL 13MMDX40CM
TIBIAL I/M NAIL 14MMDX40CM
TIBIAL I/M NAIL 15MMDX40CM
TIBIAL I/M NAIL 13MMDX42CM
TIBIAL I/M NAIL 14MMDX42CM
TIBIAL I/M NAIL 15MMDX42CM
TIBIAL I/M NAIL 11MMDX44CM
TIBIAL I/M NAIL 13MMDX44CM
TIBIAL I/M NAIL 14MMDX44CM
TIBIAL I/M NAIL 11MMDX46CM
TIBIAL I/M NAIL 12MMDX46CM
TIBIAL I/M NAIL 13MMDX46CM
Code Information Item Numbers: 00225326015 00225328015 00225330015 00225332014 00225332015 00225334014 00225334015 00225336014 00225336015 00225338014 00225338015 00225340013 00225340014 00225340015 00225342013 00225342014 00225342015 00225344011 00225344013 00225344014 00225346011 00225346012 00225346013 Lot Codes: 60689046 60689046R 60689048 60689048R 60541593 60541593R 60708943 60708943R 60733116 60733116R 60718442 60738224 60738224R 60747428 60541594 60759282 60759282R 60729914 60748950 60748950R 60750986 60750986R 60753362 60753362R 60837656 60837656R 60837650 60837657 60837657R 60837655 367894 60848473 367894R 60848473R 368331 60848488 60848488R 368105 368327 368105R 368327R 60848481 60848484 60848481R 60848484R 60858220 368330 368330R 368235 368395 60858225 368235R 368395R 60858225R 368428 368433 368403 368415 368422 368442 368403R 368415R 368422R 368442R 368394 368409 368410 368421 368429 368434 368437 368438 368439 368440 368441 60848485 368394R 368409R 368439R 368440R 368441R 60848485R 60858223 60933764 60973733 60973733R 60976652 60973738 60985622 60985622R 60985623 60985623R 60985624 60985625 60985625R 61040177 61040177R 61040179 60984603 61003748 61048029 61003748R 61040178 369111 61079864 61079864R 369093 369104 369116 369115 369113 369181 60973739 60973739R 61143370 61143370R 61188445 61170168 61170168R 61172763 61172763R 61187613 61187613R 61184356 61187623 61184356R 61187623R 61194163 61244786 61244786R 61277990 61277990R 61263725 61263726 61263725R 61267999 61277985 61277986 61277988 61277985R 61277986R 61285984 61276112 61277989 61285988 61307940 61315092 61315092R 61307938 61307942 61322926 61307942R 61322926R 61324290 61324291 61324291R 61327784 61327787 61327784R 61327787R 61298479 61327773 61327781 61327785 61327781R 61329351 61332785 61343281 61332786 61341150 61344241 61341150R 61344243 61351690 61351690R 369506 61382431 61382431R 61388034 61389804 61428542 369828 369856 369859 61441063 61458950 61458952 61468145 61490767 61475208 61523842 61621127 61641826 370641 62011700 370654 370658 370687 370728 370729 370661 370891 371002 37107538 62406368 37108810 37108407 37108664 37108549 62513247 37107529 62513246 37107535 37107541 62505134 62513239 37107537 37107531 62497631 37217627 37219495 37219822 37217593 37217607 37217618 37217598 37217600 37217613 37217634 37217616 37217597 37217606 37217601 37217617 37217628 37217632 37219497 37217635 37217585 37220600 37217630 37219957 37217612 37217619 37109120 37109397 37109385 37109365 37109360 37109415 37109399 37109366 37109361 37109374 37109384 37109395 37109363 63446859 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Service
574-371-3071
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. Additionally, Zimmer Biomet will also notify surgeons that have implanted the affected product within the past 12 months. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a
Quantity in Commerce 1499
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ZIMMER, INC.
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