Z-0176-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Reason for Recall
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Distribution Pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Code Information
UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101