Z-0534-2020 Class II Terminated
FDA device recall Z-0534-2020 was initiated by Nextremity Solutions on October 9, 2019 and is designated Class II. Reason for recall: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length The recall status is terminated (terminated June 24, 2020). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- October 9, 2019
- Termination Date
- June 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Reason for Recall
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: M1151 UDI: 00817701022558