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U.S. Department of Health and Human Services

Class 2 Device Recall Ennovate

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  Class 2 Device Recall Ennovate see related information
Date Initiated by Firm July 13, 2020
Create Date July 21, 2022
Recall Status1 Terminated 3 on April 26, 2024
Recall Number Z-1428-2022
Recall Event ID 90503
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Code Information UDI-DI: 04046964719622
Recalling Firm/
Manufacturer
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Linday Chromiak
610-984-9072 Ext. 5072
Manufacturer Reason
for Recall
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
FDA Determined
Cause 2
Component design/selection
Action An Urgent Field Safety Notification was issued July 13, 2020 sent USPS certified mail to distributors. The notification identified the product as Ennovate Removal Key (SZ380R) and addressed correct usage of said device, referencing section K of the Surgical Technique. Distributors are to identify and notify customers if further distributed. Distributors and customers are to review the notice, notify end users, and return the "Medical Device Field Safety Notification Form" to Aesculap via email at qa-recalls@aesculapusa.com.
Quantity in Commerce 16
Distribution United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
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.
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