Recall Z-1045-2019
Smith & Nephew, Inc. · initiated December 10, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , 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.
Codes / lots: Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R
Reason for recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
FDA-determined 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.
Details
- Recall number
- Z-1045-2019
- Initiated
- December 10, 2018
- Terminated
- November 3, 2020
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 46 units
- Distribution
- US Distribution to OR and TN; and Internationally to: Japan.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1042-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-1043-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-1044-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |