CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Ennovate Mis Removalkey Short, product recalled
Aesculap Implant Systems is recalling Ennovate Mis Removalkey Short, distributed nationwide in the US. The recall was initiated on 13 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1428-2022
- FDA event ID
- 90503
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jul 2020
- FDA classified
- 21 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Jul 2020 | Recall initiated by company | |
| 21 Jul 2022 | Classified by FDA | +738 days |
| 27 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Where it was distributed
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 04046964719622
Where was it sold?
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aesculap Implant Systems
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