Smith & Nephew, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1043-2019)

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 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.

Product Classification:

Class II

Date Initiated: December 10, 2018

Date Posted: April 3, 2019

Recall Number: Z-1043-2019

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: 65 units

Code Information:

Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated