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U.S. Department of Health and Human Services

Class 2 Device Recall N/A

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 Class 2 Device Recall N/Asee related information
Date Initiated by FirmJune 30, 2021
Create DateJuly 19, 2022
Recall Status1 Terminated 3 on April 17, 2024
Recall NumberZ-1406-2022
Recall Event ID 90537
Product Classification Bender - Product Code HXW
ProductLEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Code Information LOT: 2930901A
FEI Number 2916714
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946
Manufacturer Reason
for Recall		Customized coronal rod benders may deform the implant when used with the spinal system devices.
FDA Determined
Cause 2		Device Design
ActionA recall notification titled "Medical Device Market Withdrawal Notification" was emailed June 30, 2021. The letter identifies the affected product as Customized Coronal Rod Benders TEK 1939 and TEK 1940 and requests the customer to 1) Identify affected inventory, 2) Discontinue use, 3) Submit the acknowledgement form and 4) Contact AIS Customer Service to arrange for return of affected product at (866) 229-3002.
Quantity in Commerce2 pieces
DistributionUnited States: CO
Total Product Life CycleTPLC 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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