Z-0827-2020Class II

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Name: Z-0827-2020 Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Creator: Medicrea International
Published: 2019-09-16
License: https://open.fda.gov/license/

Medicrea International / initiated 2019-09-16 / Open, Classified / root cause: manufacturing process

FDA source

Medicrea International began a recall of Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 on 2019-09-16. FDA classified it as Class II and gives the reason as "Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0827-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-16
Posted: 2020-01-24
Recalling firm: Medicrea International
Product: Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medicrea International issued letter dated 9/12/19 to US Distributor stating reason for recall, health risk and action to take: 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 organisations. Please inform MEDICREA of any adverse events concerning the use of the subject devices 2. Please comply with any local laws or regulations concerning the notification of adverseevents to your National Competent Authority. 3. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Contact: 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: 30 units
Distribution: Nationwide
Product codes and lots: Lot number(s) : 18G0037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-29	2020-01-18
Z-0828-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-29	2020-01-18

Product code KWP

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)