Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l
Summary
The FDA issued a Class II for Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental a by Aesculap Implant Systems LLC. Reason: Potential for the incorrect screw to be included in the package..
Details
Source
Device Recall
External ID
Z-1638-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Lot/Code Info: GUIDID: 04046964989728 Lot Number: 52758014
Quantity Affected: 6 units
Reason for Recall
Potential for the incorrect screw to be included in the package.
Distribution
GA, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-15
Company
Center Valley, PA
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
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 (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1638-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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