FDA recall Z-2624-2017
Smith & Nephew, Inc. · Class II · device
Product
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Reason for recall
The incorrect Loctite adhesive was used to assemble the impactor heads.
Distribution
US distribution to TN
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-30
- Report date
- 2017-07-05
- Termination date
- 2021-12-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2624-2017