Class 2 Device Recall MDN Nails

• Date Initiated by Firm: April 28, 2017
• Create Date: June 15, 2017
• Recall Status: Terminated on May 15, 2019
• Recall Number: Z-2596-2017
• Recall Event ID: 77141
• 510(K)Number: K965098
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM; FEM IM NAIL 14MMDX32CM; FEM IM NAIL 15MMDX32CM; FEM IM NAIL 16MMDX32CM; FEM IM NAIL 14MMDX34CM; FEM IM NAIL 15MMDX34CM; FEM IM NAIL 16MMDX34CM; FEM IM NAIL 14MMDX36CM; FEM IM NAIL 15MMDX36CM; FEM IM NAIL 14MMDX38CM; FEM IM NAIL 15MMDX38CM; FEM IM NAIL 11MMDX40CM; FEM IM NAIL 13MMDX40CM; FEM IM NAIL 14MMDX40CM; FEM IM NAIL 15MMDX40CM; FEM IM NAIL 11MMDX42CM; FEM IM NAIL 12MMDX42CM; FEM IM NAIL 13MMDX42CM; FEM IM NAIL 14MMDX42CM; FEM IM NAIL 15MMDX42CM; FEM IM NAIL 11MMDX44CM; FEM IM NAIL 12MMDX44CM; FEM IM NAIL 13MMDX44CM; FEM IM NAIL 14MMDX44CM; FEM IM NAIL 10MMDX46CM; FEM IM NAIL 11MMDX46CM; FEM IM NAIL 12MMDX46CM; FEM IM NAIL 13MMDX46CM; FEM IM NAIL 14MMDX46CM; FEM IM NAIL 10MMDX48CM; FEM IM NAIL 11MMDX48CM; FEM IM NAIL 12MMDX48CM; FEM IM NAIL 13MMDX48CM; FEM IM NAIL 14MMDX48CM; FEM IM NAIL 13MMDX50CM; FEM IM NAIL 14MMDX50CM
• Code Information: Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012 00225242013 00225242014 00225242015 00225244011 00225244012 00225244013 00225244014 00225246010 00225246011 00225246012 00225246013 00225246014 00225248010 00225248011 00225248012 00225248013 00225248014 00225250013 00225250014 Lot Numbers: 60684923 60680624 60680627 60680627R 60680623 60680623R 60680629 60680629R 60680615 60680628 60680615R 60680628R 60680625 60680619 60680619R 60691710 60691708 60691713 60691708R 60732923 60732923R 60691711 60732925 60745751 60691711R 60745751R 60732924 60747393 60747393R 367355 60753357 367355R 60753357R 60721966 60747408 60721966R 367348 60751917 60751917R 60753355 60753356 60758098 60753355R 60715104 60758099 60735584 60735585 60735585R 367352 60789431 60789432 60789431R 367354 60747405 60797046 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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: 27279
• 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.