Recall Z-2625-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
| Date | Jun 12, 2017 (initiated May 30, 2017) |
| Status | Terminated |
| Reason | The incorrect Loctite adhesive was used to assemble the impactor heads. |
| Root cause | Process control |
| Action | The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed. |
| Quantity | 46 units |
| Distribution | US distribution to TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162775 | Legion Cone System Smith & Nephew, Inc., Jan 13, 2017 |