PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 9, 2022 Initiated: September 20, 2022 #Z-0177-2023

Product Description

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.

Details

Units Affected
2 units
Distribution
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.. Recalled by Baxter Healthcare Corporation. Units affected: 2 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0177-2023.