Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
This recall has been terminated (originally issued September 18, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- September 18, 2018
- Terminated
- May 8, 2019
- Recall Number
- Z-0200-2019
- Quantity
- 6 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Distribution
US Distribution to the states of: KS and TN.
Lot / Code Info
Lot 17LM05396
Root Cause
Process control
Action Taken
The firm, Smith & Nephew, notified their consignees with a notice entitled " Urgent Medical Device Recall Notice" by email on 09/18/2018. The notice The notice explained the problem and the potential hazard and requested return of the recalled units. The consignees are instructed to do the following: Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainders of the form sign and send to FieldActions@smith-nephew.com or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.