Z-0104-2022 Class II Terminated
FDA device recall Z-0104-2022 was initiated by K2M, Inc on September 8, 2021 and is designated Class II. Reason for recall: Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision … The recall status is terminated (terminated May 17, 2024). Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 8, 2021
- Termination Date
- May 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Reason for Recall
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
Distribution Pattern
Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Code Information
Lots CCUNA, HYMJ, KNCU