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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Vantage

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  Class 2 Device Recall Exactech Vantage see related information
Date Initiated by Firm November 21, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0587-2024
Recall Event ID 93507
510(K)Number K152217  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Exactech Vantage Ankle System, Catalog Numbers:
a) 350-21-04,
b) 350-22-03
Code Information a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		 Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA Determined
Cause 2		 Packaging change control
Action Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Distribution US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = EXACTECH INC
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