Z-0777-2020 Class II Terminated

Recalled by Nextremity Solutions — Warsaw, IN

FDA device recall Z-0777-2020 was initiated by Nextremity Solutions on November 11, 2019 and is designated Class II. Reason for recall: Components 2mm shorter than indicated on the package label The recall status is terminated (terminated September 10, 2020). Affected quantity: 86 units.

Recall Details

Product Type
Devices
Report Date
January 15, 2020
Initiation Date
November 11, 2019
Termination Date
September 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
86 units

Product Description

Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST

Reason for Recall

Components 2mm shorter than indicated on the package label

Distribution Pattern

Nationwide

Code Information

Lot Number: M1267 UDI: 00817701023166