Data Foundry

Medical device recalls 2020

Medicrea Pass LP Blunt K-wire 01 — Class II medical device recall Z-0828-2020

Ongoing recall by Medicrea International, reported 2020-01-29, distributed nationwide. Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Recall numberZ-0828-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedicrea International, Rillieux La Pape, France
Recall initiated2019-09-16
Classified2020-01-18
Reported by FDA2020-01-29
DistributedNationwide (US)
Quantity190 units
Lot numbers18F0138, 18G0038, 18G0368, 19H0009

Product

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Reason for recall

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

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-0828-2020. 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.