—#142377

Product

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K951987
Affected lot / code info: Batch # 15GM07831

Why it was recalled

One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

Root cause (FDA determination)

Process design

Action the firm took

The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: FieldActions@smith-nephew.com, even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: jason.sells@smith-nephew.com.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to states of:FL, MO, IN and TX.

Timeline

Recall initiated: 2015-11-09
Posted by FDA: 2016-01-04
Terminated: 2016-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142377. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.