| Class 2 Device Recall Equinoxe | |
Date Initiated by Firm | September 25, 2020 |
Create Date | October 29, 2020 |
Recall Status1 |
Terminated 3 on May 01, 2023 |
Recall Number | Z-0308-2021 |
Recall Event ID |
86590 |
510(K)Number | K092900 K101909 |
Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
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Product | Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. |
Code Information |
Catalog: 304-22-07; Serial Range: 4971292-4971303 |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | Courtney Senter 352-377-1140 |
Manufacturer Reason for Recall | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
FDA Determined Cause 2 | Process control |
Action | The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020.
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 Recall Inventory Response Form to Exactech. |
Quantity in Commerce | 12 devices |
Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = PHX
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