ENNOVATE recallZ-1429-2022 · Aesculap Implant Systems LLC · initiated Nov 18, 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. Redesign of removal key.
FDA root cause category: Component design/selection
What the company is doing
An Urgent Field Safety Notification was issued November 18, 2020 sent USPS certified mail to distributors regarding removal of Ennovate Removal Key Short (SZ380) from the field. The affected Ennovate MIS Removal Key Short (SZ380R) in the field is to be exchanged with an improved design version under the same article number manufactured after June 01, 2020. Distributors are to identify and notify customers of this action. Distributors and customers are to identify the affected version in inventory and return it to Aesculap and submit the Acknowledgment Form via email at [email protected].
Recall details
- Recall number
- Z-1429-2022
- Status
- Terminated
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 17
- Product code
- LXH
- Distribution
- United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & 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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