Use cautionMedical device recall · FDA · Published July 13, 2020
Aesculap Implant Systems Recalls ENNOVATE MIS Removal Key Short: Spinal Fixation Risk
Aesculap recalls ENNOVATE MIS Removal Key Short (SZ380R) due to risk of spinal fixation arm fracture if 90-degree angle not met during use. Affected users should contact for details.
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.
Take action
Contact the company
📍Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer
Aesculap recalls its ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) because it can fracture or break the spinal fixation arm if the 90-degree angle isn't maintained when using the removal key with spinal fixation systems. This poses a risk of serious injury during spinal surgery procedures. Read more at govinfonow.com/recall/64734-aesculap-implant-systems-recalls-ennovate-mis-removal-key-short-spinal.
“Aesculap Implant Systems Recalls ENNOVATE MIS Removal Key Short: Spinal Fixation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64734-aesculap-implant-systems-recalls-ennovate-mis-removal-key-short-spinal. Based on FDA recall #Z-1428-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2022%22&limit=1).
Aesculap Implant Systems LLC voluntarily recalled the ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) on July 13, 2020, according to the FDA. The device may fracture if the removal key is not used at a 90-degree angle.
How to tell if you have it
Brand: Aesculap
Product: ENNOVATE MIS REMOVALKEY SHORT
Product code: SZ380R
UDI-DI: 04046964719622
The hazard
The spinal fixation arm may fracture or break at the downtube instrument if the 90-degree angle is not met when using the removal key with the spinal fixation system, according to the FDA.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since August 10, 2017. Other recent recalls of similar products include Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026), Innovasis Anti-Torque Vector Pedicle Screw LS-749 Recall (May 22, 2026), and Olympus HX-400U-30 Ligating Device Recall (October 30, 2025).
How to tell if you have this one
Check for the product code SZ380R on the removal key. The device was sold with UDI-DI: 04046964719622.
Brand
Aescul: Aesculap Implant Systems LLC
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Aesculap Implant Systems LLC for specific instructions on how to verify the product and get further assistance.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Illinois, Michigan, Ohio, Texas.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1428-2022 (July 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1428-2022 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.