Recall Z-0573-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
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.
| Date | Jan 4, 2016 (initiated Nov 9, 2015) |
| Status | Terminated |
| Reason | 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 | Process design |
| Action | 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 |
| Quantity | 20 units |
| Distribution | US Distribution to states of:FL, MO, IN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Aug 22, 1995 |