Z-0827-2020 Class II Ongoing
FDA device recall Z-0827-2020 was initiated by Medicrea International on September 16, 2019 and is designated Class II. Reason for recall: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- September 16, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Reason for Recall
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Distribution Pattern
Nationwide
Code Information
Lot number(s) : 18G0037