Recall Z-1043-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
| Date | Dec 10, 2018 |
| Status | Terminated |
| Reason | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch |
| Root cause | Device Design |
| Action | The firm, smith&nephew, initiated the recall by email with an "Urgent Medical Device Recall Notice" letter dated 12/10/18 to the customers on 12/10/2018. Letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -Inspect your inventory and locate any devices from the listed product and batch numbers and quarantine them immediately. - If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. -Complete and return the Response Form to FieldActions@smith-nephew.com or fax to |
| Quantity | 65 units |
| Distribution | US Distribution to OR and TN; and Internationally to: Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173331 | JOURNEY II XR Knee Instruments Smith & Nephew, Inc., Nov 16, 2017 |