Z-0176-2023 Class II Terminated
FDA device recall Z-0176-2023 was initiated by Baxter Healthcare Corporation on Sep 20, 2022 and is designated Class II. 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. The recall status is terminated (terminated Aug 4, 2026). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 20, 2022
- Termination Date
- Aug 4, 2026
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0176-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026