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U.S. Department of Health and Human Services

Class 2 Device Recall A.L.P.S. MinimallyInvasive (MIS) and Mesh Calcaneus Plating System

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  Class 2 Device Recall A.L.P.S. MinimallyInvasive (MIS) and Mesh Calcaneus Plating System see related information
Date Initiated by Firm October 25, 2017
Create Date April 03, 2018
Recall Status1 Terminated 3 on May 01, 2020
Recall Number Z-1306-2018
Recall Event ID 79393
510(K)Number K111663  K093474  
Product Classification Plate, fixation, bone - Product Code HRS
Product A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Code Information Package Lot: 989430; Lot Etched on Product: P0284
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		 The drill guides were manufactured with the incorrect color anodization.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action DISTRIBUTORS: Review this notification and ensure that affected team members are aware of the contents. 1. Review this notification and ensure affected team members 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. Immediately 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. a. Request a Return Authorization Number 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 22
Distribution Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
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 = HRS and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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