ENNOVATE recallZ-1428-2022 · Aesculap Implant Systems LLC · initiated Jul 13, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
An Urgent Field Safety Notification was issued July 13, 2020 sent USPS certified mail to distributors. The notification identified the product as Ennovate Removal Key (SZ380R) and addressed correct usage of said device, referencing section K of the Surgical Technique. Distributors are to identify and notify customers if further distributed. Distributors and customers are to review the notice, notify end users, and return the "Medical Device Field Safety Notification Form" to Aesculap via email at [email protected].
Recall details
- Recall number
- Z-1428-2022
- Status
- Terminated
- Initiated by the company
- Jul 13, 2020
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 16
- Product code
- LXH
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Product description
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Code information (models, lots, serial numbers)
UDI-DI: 04046964719622
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENNOVATE SZ380RAesculap AG · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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