CLASS II ONGOING Device recall · Reported 29 Jan 2020 · FDA Enforcement Report

Medicrea Pass LP Blunt K-wire-Nitinol Product reference: A06010140 recalled

Medicrea International is recalling Medicrea Pass LP Blunt K-wire-Nitinol Product reference: A06010140, distributed nationwide in the US. The recall was initiated on 16 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

Quantity recalled190 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0828-2020
FDA event ID: 84595
Recalling firm: Medicrea International, Rillieux La Pape
Classification: Class II
Status: Ongoing
Recall initiated: 16 Sep 2019
FDA classified: 18 Jan 2020
Reported: 29 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Sep 2019	Recall initiated by company
18 Jan 2020	Classified by FDA	+124 days
29 Jan 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84595

This product is part of a recall event; the main page for the event is Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130 recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jan 2020	CLASS II	Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130 recalled	Medicrea International	Device Malfunction	Nationwide

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