Z-1156-2020Class II

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Name: Z-1156-2020 Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Creator: Medicrea International
Published: 2019-10-02
License: https://open.fda.gov/license/

Medicrea International / initiated 2019-10-02 / Terminated / root cause: manufacturing process

FDA source

Medicrea International began a recall of Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010 on 2019-10-02. FDA classified it as Class II and gives the reason as "Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1156-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Posted: 2020-02-12
Terminated: 2021-02-08
Recalling firm: Medicrea International
Product: Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medicrea Issued Voluntary Product Recall dated 10/3/19 stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. Contact person for this action is given below: Tim Huntington MEDICREA USA QA Manager Tel : 646-490-2426 Mail : [email protected]
Quantity in commerce: 14 units
Distribution: OH, VA
Product codes and lots: Lot Numbers l9B0570; 19B0572

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1156-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1156-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code MAX

K163595Class IIIMPIX 3D Print CagesMedicrea International SA / cleared 2017-11-13

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)