The Recall Desk
SevereFDA (Devices)·Z-1042-2019·Announced 2019-04-03

Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device associated with a significant injury (bone fracture) during use, which aligns with the rubric criteria for a Severe (Score 4) classification.

Plain-English summary

Smith & Nephew, Inc. is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch, Reference 74013986. This reusable surgical instrument is used to prepare the proximal tibia to receive a Journey II XR tibial baseplate.

The recall is being issued because of a higher than anticipated occurrence of bone fracture during the use of the instrument. The affected units were distributed in the United States to Oregon and Tennessee, and internationally to Japan.

The affected batch numbers are 17JGA0020, 17JGA0020A, 17JGA0020B, 17JGA0026, 17JGA0026A, 17JGA0026B, 17JGA0032A, 17JGA0032B, 17JGA0042, 17JGA0042A, and 17JGA0042R. Healthcare facilities and users should stop using the affected instruments and contact Smith & Nephew for further instructions.

The recalled product

Product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 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.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
65

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Batch Numbers: 17JGA0020
  • 17JGA0020A
  • 17JGA0020B
  • 17JGA0026
  • 17JGA0026A
  • 17JGA0026B
  • 17JGA0032A
  • 17JGA0032B
  • 17JGA0042
  • 17JGA0042A
  • 17JGA0042R

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

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Same hazard · bone fracture

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