JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 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.
Recall
- Recall Number
- Z-1044-2019
- Event Number
- 81766
- Firm
- Smith & Nephew, Inc.
- FEI Number
- 1020279
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 10, 2018
- Terminated
- November 3, 2020
- Address
- 1450 E Brooks Rd, Memphis, TN, 38116-1804
Description
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 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.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
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 [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. If you have any questions or concerns regarding this recall please contact [email protected].
US Distribution to OR and TN; and Internationally to: Japan.
65 units