FDA recall Z-0177-2023

Product

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head 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-0177-2023