Z-0753-2020Class II

Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x...

Name: Z-0753-2020 Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x...
Creator: Medicrea International
Published: 2019-06-27
License: https://open.fda.gov/license/

Medicrea International / initiated 2019-06-27 / Terminated / root cause: manufacturing process

FDA source

Medicrea International began a recall of Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM... on 2019-06-27. FDA classified it as Class II and gives the reason as "It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that...". 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-0753-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Posted: 2019-12-30
Terminated: 2020-11-19
Recalling firm: Medicrea International
Product: Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On June 27, 2019, Medicrea begin emailing a "field safety correction action - Recall" notification to affected consignees. In addition to informing the consignee about the recall, the notification asked customers to do the following: 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 organisations. a) Please provide contact details so that MEDICREA can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 4.. Please inform MEDICREA of any adverse events concerning the use of the subject devices Please comply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority. 5. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 6. We request that you respond to this notice within 07 calendar days from the date of receipt.
Quantity in commerce: 210 Pedicle Screws
Distribution: US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal
Product codes and lots: Lot #/Expiration Date: 19A0630/January 03, 2029 19B0329 /January 21th, 2029 19C0734 /March 03, 2029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30

Product code NKB

K141398Class IIPass Lp Spinal SystemMedicrea International SA / cleared 2015-01-09

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)