Z-1467-2023 Class II Ongoing
FDA device recall Z-1467-2023 was initiated by Wright Medical Technology, Inc. on April 10, 2023 and is designated Class II. Reason for recall: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. The recall status is ongoing. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- April 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Reason for Recall
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 00889797101035, Lot Number 1737413