Smith & Nephew, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1045-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 10, 2018

Date Posted: April 3, 2019

Recall Number: Z-1045-2019

Event ID: 81766

Reason for Recall:

Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

Status: Terminated

Product Quantity: 46 units

Code Information:

Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R

Distribution Pattern:

US Distribution to OR and TN; and Internationally to: Japan.

Voluntary or Mandated:

Voluntary: Firm initiated