Device product
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Z-2309-2026
Product summary
- Event
- Event 98911
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1818 units
- Official record key
device-enforcement:Z-2309-2026
Official wording
Reason: 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Code information: UDI-DI 00848782027514; Lot Number FA22CHQ
Distribution pattern: Worldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom.
Derived failure modes
-
Unknown
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.