CLASS II ONGOING Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130 recalled
Medicrea International is recalling Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130, 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
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-0827-2020
- 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
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
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 Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Where it was distributed
Nationwide
Questions about this recall
Is Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130 recalled?
Yes. Medicrea International recalled Medicrea Pass LP Trocar K-wire-Nitinol Product reference : A06010130 on 16 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-0827-2020.
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) : 18G0037
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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