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Class 2 Device Recall Exactech Opetrak Logic |
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Date Initiated by Firm |
November 21, 2023 |
Date Posted |
January 18, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0583-2024 |
Recall Event ID |
93507 |
510(K)Number |
K111400 K150890
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
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Code Information |
a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497;
b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353;
c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341;
d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561 |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 Nw 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact |
352-377-1140
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Manufacturer Reason for Recall |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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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
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.
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