Z-1436-2021Class II

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through...

Name: Z-1436-2021 DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through...
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2021-04-01
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2021-04-01 / Terminated

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement... on 2021-04-01. FDA classified it as Class II and gives the reason as "Inability for the user to inject the paste from the syringe into the target location". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1436-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-01
Posted: 2021-04-19
Terminated: 2022-12-19
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
Product code: GXP Methyl Methacrylate For Cranioplasty
Reason for recall: Inability for the user to inject the paste from the syringe into the target location.
FDA root cause: Under Investigation by firm
Action: On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
Quantity in commerce: 321 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Product codes and lots: Lot: DI20311,DI20307 Product Code (UDI): 07613327123265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1436-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1436-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-19

Product code GXP

K143661Class IIDirectInjectStryker / cleared 2015-09-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)