Medicrea International: Medical Device Recall in 2020 - (Recall #: Z-0753-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 27, 2019

Date Posted: January 8, 2020

Recall Number: Z-0753-2020

Event ID: 84273

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.

Status: Terminated

Product Quantity: 210 Pedicle Screws

Code Information:

Lot #/Expiration Date: 19A0630/January 03, 2029 19B0329 /January 21th, 2029 19C0734 /March 03, 2029

Distribution Pattern:

US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal

Voluntary or Mandated:

Voluntary: Firm initiated