Aesculap Implant Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1428-2022)

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:

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Product Classification:

Class II

Date Initiated: July 13, 2020

Date Posted: July 27, 2022

Recall Number: Z-1428-2022

Event ID: 90503

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.

Status: Terminated

Product Quantity: 16

Code Information:

UDI-DI: 04046964719622

Distribution Pattern:

United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.

Voluntary or Mandated:

Voluntary: Firm initiated