Medicrea Pass LP — Class II medical device recall Z-0753-2020
Terminated recall by Medicrea International, reported 2020-01-08, distributed in AZ, CO, FL, NY, OH, PA, TX. It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. P
| Recall number | Z-0753-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, N/A, France |
| Recall initiated | 2019-06-27 |
| Classified | 2019-12-30 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2020-11-19 |
| Distributed | AZ, CO, FL, NY, OH, PA, TX |
| Countries outside the US | BE, CN, ES, FR, PT, ZA |
| Quantity | 210 pedicle |
| UPC / GTIN / UDI-DI | 03613720177906 |
| Lot numbers | 19A0630, 19B0329 |
| Model numbers | B02217545 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0753-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.