Recall Z-2625-2017
Smith & Nephew, Inc. · initiated May 30, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
Reason for recall
The incorrect Loctite adhesive was used to assemble the impactor heads.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2625-2017
- Initiated
- May 30, 2017
- Posted by FDA
- June 12, 2017
- Terminated
- December 10, 2021
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 46 units
- Distribution
- US distribution to TN
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2624-2017 Class II | LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c)…The incorrect Loctite adhesive was used to assemble the impactor heads. | 05/30/2017Terminated |