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.
This recall has been terminated (originally issued December 10, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- December 10, 2018
- Terminated
- November 3, 2020
- Recall Number
- Z-1043-2019
- Quantity
- 65 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Distribution
US Distribution to OR and TN; and Internationally to: Japan.
Lot / Code Info
Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B
Root Cause
Device Design
Action Taken
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 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 FieldActions@smith-nephew.com.