FDA recall Z-0176-2023

Baxter Healthcare Corporation · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2022-09-20
Report date: 2022-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2023