Z-1428-2022Class II

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Name: Z-1428-2022 ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Creator: Aesculap Implant Systems LLC
Published: 2020-07-13
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2020-07-13 / Terminated / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R on 2020-07-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1428-2022
Classification: Class II
Status: Terminated
Initiated: 2020-07-13
Posted: 2022-07-21
Terminated: 2024-04-26
Recalling firm: Aesculap Inc
Product: ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Field Safety Notification was issued July 13, 2020 sent USPS certified mail to distributors. The notification identified the product as Ennovate Removal Key (SZ380R) and addressed correct usage of said device, referencing section K of the Surgical Technique. Distributors are to identify and notify customers if further distributed. Distributors and customers are to review the notice, notify end users, and return the "Medical Device Field Safety Notification Form" to Aesculap via email at [email protected].
Quantity in commerce: 16
Distribution: United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Product codes and lots: UDI-DI: 04046964719622

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1428-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)