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. Redesign of removal key.
Take action
Contact the company
📍Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
“Aesculap Implant Systems Recalls Short Removal Key Due to Spinal Fixation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63892-aesculap-implant-systems-recalls-short-removal-key-due-to-spinal. Based on FDA recall #Z-1429-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2022%22&limit=1).
Aesculap Implant Systems LLC recalled the ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) due to fracture risks, according to the FDA. The Food and Drug Administration announced the voluntary Class II recall on November 18, 2020.
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 a 90-degree angle is not met when using the removal key. The company is redesigning the removal key to address this issue.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has issued 26 other recalls since August 10, 2017. Recent brand recalls include a March 21, 2023 notice for the Caiman Articulating D5/360MM regarding spring failure and a July 20, 2023 recall of Brain Ventricles Implant Systems due to visual field obstruction risks. Other recent recalls of similar products include the MINOP Trocar 150mm (January 15, 2026) and the Olympus HX-400U-30 Ligating Device (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 a UDI-DI number 04046964719622.
Brand
Aescul: Aesculap Implant Systems LLC
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device
Look for the product code SZ380R on the removal key or UDI-DI number 04046964719622.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Michigan, New Hampshire, Ohio, South Carolina, Texas.
Recall timeline
FDA terminated this recall 4.1 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-1429-2022 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1429-2022 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.