Device product
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Z-2648-2017
Product summary
- Event
- Event 77309
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2648-2017
Official wording
Reason: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Code information: LOT 1699599
Distribution pattern: AZ, IL & KS
Derived failure modes
-
Labeling or packaging
incorrectly labeled