Recall Z-0200-2019

Reason for recall

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

FDA-determined 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.