Z-1234-2020Class II

Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

Name: Z-1234-2020 Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Creator: Medicrea International
Published: 2019-11-11
License: https://open.fda.gov/license/

Medicrea International / initiated 2019-11-11 / Terminated / root cause: design

FDA source

Medicrea International began a recall of Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500 on 2019-11-11. FDA classified it as Class II and gives the reason as "Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)". 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-1234-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-11
Posted: 2020-03-02
Terminated: 2020-10-14
Recalling firm: Medicrea International
Product: Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
Root cause tag: design
FDA root cause: Device Design
Action: Medicrea issued notification dated 11/11/19 via email, 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. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA 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: Karine TROGNEUX-MEDICREA INTERNATIONAL Regulatory Affairs Manager Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : [email protected]
Quantity in commerce: 3 units
Distribution: CA, FL
Product codes and lots: Lot Number:19H0108 Exp.Date: 19/08/2029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14

Product code NKB

K190376Class IIPASS LP Spinal SystemMedicrea International SA / cleared 2019-05-02

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)