Lower riskMedical device recall · FDA · Published July 15, 2022
Aesculap ENNOVATE Set Screws Recall: Incorrect Screw Risk
Aesculap recalls ENNOVATE sterile set screws for spinal stabilization due to potential incorrect screw inclusion in packages. Affected units include specific lot numbers and article codes.
“Aesculap ENNOVATE Set Screws Recall: Incorrect Screw Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60359-aesculap-ennovate-set-screws-recall-incorrect-screw-risk. Based on FDA recall #Z-1638-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1638-2022%22&limit=1).
Aesculap Implant Systems LLC voluntarily recalled Aesculap ENNOVATE SET SCREW STERILE implants on July 15, 2022, according to the FDA. The hazard is the potential for an incorrect screw to be included in the package.
How to tell if you have it
Brand: Aesculap
Product: Aesculap ENNOVATE SET SCREW STERILE-implants
Article Number: 52758014
GUIDID: 04046964989728
Lot Number: 52758014
Distribution: GA, TX
The hazard
The recall involves a potential for the incorrect screw to be included in the package. Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since 2017-08-10. Other recent recalls include a visual field obstruction risk for Aesculap Brain Ventricles Implant Systems (2023-07-20), an incorrect product code risk for Aesculap Surgical Needle (2023-05-18), and a spring falling out hazard for Aesculap Caiman Articulating D5/360MM (2023-03-21). Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall (2026-02-25), XTANT Medical Xpress Pedicle Screw System (2026-02-18), and Tornier Perip Screw Recall (2025-12-19).
How to tell if you have this one
Check for the article number 52758014 or lot number 52758014 on the packaging. The product is used for spinal stabilization in the lumbar, thoracic, and sacral regions.
Brand
Aesculap
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Package Contents
Verify that the package contains the correct screw type by checking the article number or lot number on the packaging.
Where it went and when
Where it was distributed
Distributed in Georgia and Texas.
Listed by the agency
Not listed
FDA distribution: “GA, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Texas.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1638-2022 (July 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1638-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.