Class 2 Device Recall MDN Nail

• Date Initiated by Firm: April 28, 2017
• Create Date: June 15, 2017
• Recall Status: Terminated on May 15, 2019
• Recall Number: Z-2598-2017
• Recall Event ID: 77141
• 510(K)Number: K142281
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT; FEM IM NAIL 13MMDX32CM LEFT; FEM IM NAIL 14MMDX32CM LEFT; FEM IM NAIL 13MMDX32CM RIGHT; FEM IM NAIL 14MMDX32CM RIGHT; FEM IM NAIL 11MMDX34CM LEFT; FEM IM NAIL 13MMDX34CM LEFT; FEM IM NAIL 14MMDX34CM LEFT; FEM IM NAIL 11MMDX34CM RIGHT; FEM IM NAIL 13MMDX34CM RIGHT; FEM IM NAIL 14MMDX34CM RIGHT; FEM IM NAIL 11MMDX36CM LEFT; FEM IM NAIL 12MMDX36CM LEFT; FEM IM NAIL 13MMDX36CM LEFT; FEM IM NAIL 14MMDX36CM LEFT; FEM IM NAIL 11MMDX36CM RIGHT; FEM IM NAIL 12MMDX36CM RIGHT; FEM IM NAIL 13MMDX36CM RIGHT; FEM IM NAIL 14MMDX36CM RIGHT; FEM IM NAIL 10MMDX38CM LEFT; FEM IM NAIL 11MMDX38CM LEFT; FEM IM NAIL 12MMDX38CM LEFT; FEM IM NAIL 13MMDX38CM LEFT; FEM IM NAIL 14MMDX38CM LEFT; FEM IM NAIL 10MMDX38CM RIGHT; FEM IM NAIL 11MMDX38CM RIGHT; FEM IM NAIL 12MMDX38CM RIGHT; FEM IM NAIL 13MMDX38CM RIGHT; FEM IM NAIL 14MMDX38CM RIGHT; FEM IM NAIL 10MMDX40CM LEFT; FEM IM NAIL 11MMDX40CM LEFT; FEM IM NAIL 12MMDX40CM LEFT; FEM IM NAIL 13MMDX40CM LEFT; FEM IM NAIL 14MMDX40CM LEFT; FEM IM NAIL 10MMDX40CM RIGHT; FEM IM NAIL 11MMDX40CM RIGHT; FEM IM NAIL 12MMDX40CM RIGHT; FEM IM NAIL 13MMDX40CM RIGHT; FEM IM NAIL 14MMDX40CM RIGHT; FEM IM NAIL 10MMDX42CM LEFT; FEM IM NAIL 11MMDX42CM LEFT; FEM IM NAIL 12MMDX42CM LEFT; FEM IM NAIL 13MMDX42CM LEFT; FEM IM NAIL 14MMDX42CM LEFT; FEM IM NAIL 10MMDX42CM RIGHT; FEM IM NAIL 11MMDX42CM RIGHT; FEM IM NAIL 12MMDX42CM RIGHT; FEM IM NAIL 13MMDX42CM RIGHT; FEM IM NAIL 14MMDX42CM RIGHT; FEM IM NAIL 10MMDX44CM LEFT; FEM IM NAIL 11MMDX44CM LEFT; FEM IM NAIL 12MMDX44CM LEFT; FEM IM NAIL 13MMDX44CM LEFT; FEM IM NAIL 14MMDX44CM LEFT; FEM IM NAIL 10MMDX44CM RIGHT; FEM IM NAIL 11MMDX44CM RIGHT; FEM IM NAIL 12MMDX44CM RIGHT; FEM IM NAIL 13MMDX44CM RIGHT; FEM IM NAIL 14MMDX44CM RIGHT; FEM IM NAIL 10MMDX46CM LEFT; FEM IM NAIL 11MMDX46CM LEFT; FEM IM NAIL 12MMDX46CM LEFT; FEM IM NAIL 13MMDX46CM LEFT; FEM IM NAIL 14MMDX46CM LEFT; FEM IM NAIL 10MMDX46CM RIGHT; FEM IM NAIL 11MMDX46CM RIGHT; FEM IM NAIL 12MMDX46CM RIGHT; FEM IM NAIL 13MMDX46CM RIGHT; FEM IM NAIL 14MMDX46CM RIGHT; FEM IM NAIL 10MMDX48CM LEFT; FEM IM NAIL 11MMDX48CM LEFT; FEM IM NAIL 12MMDX48CM LEFT; FEM IM NAIL 13MMDX48CM LEFT; FEM IM NAIL 10MMDX48CM RIGHT; FEM IM NAIL 11MMDX48CM RIGHT; FEM IM NAIL 12MMDX48CM RIGHT; FEM IM NAIL 13MMDX48CM RIGHT; FEM IM NAIL 10MMDX50CM LEFT; FEM IM NAIL 11MMDX50CM LEFT; FEM IM NAIL 12MMDX50CM LEFT; FEM IM NAIL 13MMDX50CM LEFT; FEM IM NAIL 10MMDX50CM RIGHT; FEM IM NAIL 11MMDX50CM RIGHT; FEM IM NAIL 12MMDX50CM RIGHT; FEM IM NAIL 13MMDX50CM RIGHT
• Code Information: 510K: K965098,K032367 Item Numbers: 00225730004 00225730014 00225732003 00225732004 00225732013 00225732014 00225734001 00225734003 00225734004 00225734011 00225734013 00225734014 00225736001 00225736002 00225736003 00225736004 00225736011 00225736012 00225736013 00225736014 00225738000 00225738001 00225738002 00225738003 00225738004 00225738010 00225738011 00225738012 00225738013 00225738014 00225740000 00225740001 00225740002 00225740003 00225740004 00225740010 00225740011 00225740012 00225740013 00225740014 00225742000 00225742001 00225742002 00225742003 00225742004 00225742010 00225742011 00225742012 00225742013 00225742014 00225744000 00225744001 00225744002 00225744003 00225744004 00225744010 00225744011 00225744012 00225744013 00225744014 00225746000 00225746001 00225746002 00225746003 00225746004 00225746010 00225746011 00225746012 00225746013 00225746014 00225748000 00225748001 00225748002 00225748003 00225748010 00225748011 00225748012 00225748013 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• 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: 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: 24969
• 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.