Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Summary
The FDA issued a Class II for Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, Nano by Medtronic Sofamor Danek USA Inc. Reason: Engraving on implants may not match what is listed on the pouch labels..
Details
Source
Device Recall
External ID
Z-0086-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Lot/Code Info: Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
Quantity Affected: 9 units
Reason for Recall
Engraving on implants may not match what is listed on the pouch labels.
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Sofamor Danek USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Sofamor Danek USA Inc have FDA actions?
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0086-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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