Recall Z-0097-2018
Smith & Nephew, Inc. · initiated October 24, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Codes / lots: Lot number 16LM07111
Reason for recall
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
FDA-determined cause: Employee error
Action taken
Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.
Details
- Recall number
- Z-0097-2018
- Initiated
- October 24, 2017
- Product code
- JDS – Nail, Fixation, Bone
- Quantity
- 17 units
- Distribution
- US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN