Z-0610-2024 Class II Ongoing
FDA device recall Z-0610-2024 was initiated by Stryker Spine on November 1, 2023 and is designated Class II. Reason for recall: Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft. The recall status is ongoing. Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
LITe Decompression Snake Arm, REF 48080230
Reason for Recall
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Distribution Pattern
US: MD, MI, NM, TX & OUS: Canada & France.
Code Information
UDI-DI (GTIN): 07613327263909, lot # 227764.