—#158754

Product

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041106
Affected lot / code info: Lot Number 14GSM0440A

Why it was recalled

The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

Timeline

Recall initiated: 2017-09-14
Terminated: 2020-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.