Recall Z-0828-2020— Medicrea International

Name: FDA recall Z-0828-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Ongoing

Class II FDA medical device recall by Medicrea International, initiated 2019-09-16. It names one FDA 510(k) clearance: K190376. Product: Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140. Reason: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded.

Recalling firm: Medicrea International
Classification: Class II
Status: Ongoing
Initiated: 2019-09-16
Firm location: Rillieux La Pape, France

510(k) clearances named in this recall

1 on FDA's record

K190376 — PASS LP Spinal SystemMedicrea International SA·cleared 2019-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.