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U.S. Department of Health and Human Services

Class 2 Device Recall Antegrade Femoral Connecting Bolt

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  Class 2 Device Recall Antegrade Femoral Connecting Bolt see related information
Date Initiated by Firm June 18, 2018
Create Date August 17, 2018
Recall Status1 Terminated 3 on March 26, 2020
Recall Number Z-2875-2018
Recall Event ID 80543
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Connecting Bolt, Model 14-442093
Code Information ...
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.
FDA Determined
Cause 2		 Employee error
Action Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Risk Manager were advised to take the following actions: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete and return the Certificate of Acknowledgement form via email to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing the notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Distributors are encouraged to do the following: Review th notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number through Fast SMS or by emailing rgarequest@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for
Quantity in Commerce 247 units
Distribution AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI
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.
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