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Recall Observatory FDA recall evidence

Device product

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

Z-0176-2023

September 20, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90848
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0176-2023

Official wording

Reason: 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.

Code information: UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101

Distribution pattern: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.