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 18 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04046964719622

Quantity recalled17

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-1429-2022
FDA event ID: 90526
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 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

18 Nov 2020	Recall initiated by company
21 Jul 2022	Classified by FDA	+610 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. Redesign of removal key.

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, MI, NH, OH, SC & TX.

Nationwide California Colorado Michigan New Hampshire Ohio South Carolina Texas

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. Redesign of removal key.

Which lots are affected?

UDI-DI: 04046964719622

Where was it sold?

United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & 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

All 61

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023Device	CLASS II	For intraventricular recalled by Aesculap Implant Systems	Aesculap Implant Systems	Device Malfunction	Nationwide
26 Jul 2023Device	CLASS II	Aesculap Surgical Needle, straight, 3 1/2", width recalled	Aesculap Implant Systems	Packaging Defects	Nationwide
17 May 2023Device	CLASS II	Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems	Aesculap Implant Systems	Other	Nationwide
3 May 2023Device	CLASS II	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled	Aesculap Implant Systems	Labeling Errors	Nationwide
7 Sep 2022Device	CLASS II	Aesculap Ennovate Set Screw Sterile-implants are used recalled	Aesculap Implant Systems	Packaging Defects	GA, TX

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