Aesculap Implant Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1638-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

Product Classification:

Class II

Date Initiated: July 15, 2022

Date Posted: September 7, 2022

Recall Number: Z-1638-2022

Event ID: 90678

Reason for Recall:

Potential for the incorrect screw to be included in the package.

Status: Ongoing

Product Quantity: 6 units

Code Information:

GUIDID: 04046964989728 Lot Number: 52758014

Distribution Pattern:

GA, TX

Voluntary or Mandated:

Voluntary: Firm initiated