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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK Comprehensive Knee System

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  Class 2 Device Recall OPTETRAK Comprehensive Knee System see related information
Date Initiated by Firm August 30, 2021
Create Date October 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0025-2022
Recall Event ID 88570
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene Tibial Components, not sold in the USA. Also labeled as OPTETRAK All-polyethylene CR Tibial Components
Code Information Item Number (Device Identifier): 200-26-09 (10885862230034)
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Nicholas Bennett
800-392-2832
Manufacturer Reason
for Recall
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
FDA Determined
Cause 2
Process control
Action Exactech began notification to distributors and sales representatives on about 08/30/2021 via letter titled "URGENT MEDICAL DEVICE RECALL." Actions being taken by Exactech included removing all Knee and Ankle UHMWPE products labeled with an 8-year shelf life and not packaged in EVOH/Nylon bags. This will be performed in a phased approach over the next 12 months. Phase 1 includes immediately return all knee and ankle UHMWPE devices labeled with an 8-year shelf life that will be 5 years old or older by 08/31/2022 not packaged in EVOH/Nylon bags. Phase 2 includes, between 05/31/2022 to 08/31/2022, returning all remaining knee and ankle UHMWPE devices labeled with an 8-year shelf life not packaged in EVOH/Nylon bags. A communication to healthcare professionals should follow. Instructions to recipients included to ensure the notification is fully read and understood, immediately identify and quarantine any affected product in inventory, notify customers down the line if further distributed, and complete and return the Recall Inventory Response Form to Exactech via email at recalls@exac.com.
Quantity in Commerce 224 devices
Distribution Worldwide distribution - US Nationwide distribution to the states of AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of Australia, France, Germany, Japan, 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.
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