Z-0177-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Distribution Pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Code Information
UDI/DI 00615521002725, Lot Number: 22-123