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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Shoulder System

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  Class 2 Device Recall Equinoxe Shoulder System see related information
Date Initiated by Firm October 06, 2020
Create Date November 17, 2020
Recall Status1 Terminated 3 on November 13, 2023
Recall Number Z-0460-2021
Recall Event ID 86630
510(K)Number K113309  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
Code Information Catalog 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032 
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Courtney Ware Senter
352-377-1140
Manufacturer Reason
for Recall		 The product may be mislabeled.
FDA Determined
Cause 2		 Packaging process control
Action Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.
Quantity in Commerce 40 devices
Distribution US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom
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 = KWS and Original Applicant = EXACTECH, INC.
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