Home / Recalls / Medicrea International / Z-0753-2020

Z-0753-2020 Class II Terminated

Recalled by Medicrea International — Rillieux La Pape, N/A

Recall Details

Product Type
Devices
Report Date
January 8, 2020
Initiation Date
June 27, 2019
Termination Date
November 19, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
210 Pedicle Screws

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

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.

Distribution Pattern

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

Code Information

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

Other recalls by Medicrea International

  • Z-1038-2026 Class II — Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 (October 29, 2025)
  • Z-1039-2026 Class II — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 (October 29, 2025)
  • Z-1118-2025 Class II — UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 U (December 3, 2024)
  • Z-2458-2023 Class II — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B (July 12, 2023)
  • Z-2452-2023 Class II — IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122 (July 12, 2023)
  • Z-2454-2023 Class II — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar (July 12, 2023)
  • Z-2462-2023 Class II — IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) (July 12, 2023)
  • Z-2459-2023 Class II — GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A131 (July 12, 2023)
  • Z-2461-2023 Class II — IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B (July 12, 2023)
  • Z-2456-2023 Class II — IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) (July 12, 2023)