The Recall Desk
HighFDA (Devices)·Z-1638-2022·Announced 2022-09-07

Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion

Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (spine surgical implants) where incorrect components could compromise surgical safety. No injuries have been reported, but the potential for incorrect hardware in spinal stabilization procedures represents a significant patient safety concern.

Plain-English summary

Aesculap Implant Systems LLC is recalling ENNOVATE SET SCREW STERILE spine implants (Lot Number 52758014, Article Number 52758014). These implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic, and sacral spine.

The recall was initiated due to the potential for incorrect screws to be included in product packages. Six units from the affected lot were distributed in Georgia and Texas.

Healthcare facilities and surgeons who received this product should contact Aesculap Implant Systems LLC for further information and guidance on inventory verification and use.

The recalled product

Product
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Implants
Hazard
  • incorrect-component
  • packaging-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GUIDID: 04046964989728 Lot Number: 52758014

Distribution

Distributed in 2 states:

  • GA
  • TX

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