Device product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Z-1629-2026
Product summary
- Firm
- Orthalign, Inc
- Event
- Event 98516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1629-2026
Official wording
Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Code information: Lot # 25091103BB/ UDI: 00810832032427
Distribution pattern: US Nationwide distribution in the state of UT.
Derived failure modes
-
Potency or specification failure
out of specification