smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
This recall has been terminated (originally issued September 14, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- September 14, 2017
- Terminated
- August 21, 2020
- Recall Number
- Z-0092-2018
- Quantity
- 10 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Distribution
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Lot / Code Info
Lot Number 14GSM0440A
Root Cause
Mixed-up of materials/components
Action Taken
Smith & Nephew sent an Urgent Medical Device Recall Notice letter dated September 14, 2017 to consignees via email. The letter identified the affected product, problem and actions to be taken. The consignees (distributors) were directed as follows: Required Actions: 1. Please inspect your inventory and locate any unused 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 batch numbers and quantities of each batch 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.