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U.S. Department of Health and Human Services

Class 2 Device Recall Fem IM Nail 15mmdx44cm, Sterile,

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  Class 2 Device Recall Fem IM Nail 15mmdx44cm, Sterile, see related information
Date Initiated by Firm February 28, 2017
Date Posted March 20, 2017
Recall Status1 Terminated 3 on February 27, 2018
Recall Number Z-2553-2017
Recall Event ID 76629
510(K)Number K965098  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Fem IM Nail 15mmdx44cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Code Information Item Number: 00225244015, Lot Number Expiry Date Before: March 2027 
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 Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
FDA Determined
Cause 2
Packaging
Action Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 3. Assist the Zimmer Biomet sales representative quarantine all affected product. 4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: ¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax. ¿ Online: www.fda.gov/medwatch/report.htm ¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm ¿ Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com. For questions regarding this recall call 574-371-3071.
Quantity in Commerce 9867
Distribution Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
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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