FDA recall Z-0180-2023

Baxter Healthcare Corporation · Class II · device

Product

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.

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-0180-2023