Device product
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Z-2624-2017
Product summary
- Event
- Event 77413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-2624-2017
Official wording
Reason: The incorrect Loctite adhesive was used to assemble the impactor heads.
Code information: Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035
Distribution pattern: US distribution to TN
Derived failure modes
-
Unknown
The incorrect Loctite adhesive was used to assemble the impactor heads.