The Recall Desk
HighFDA (Devices)·Z-1045-2019·Announced 2019-04-03

Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

Smith & Nephew is recalling 46 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

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (bone fracture) during surgery, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Smith & Nephew, Inc. is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch (Reference 74013988). This reusable surgical instrument is used to prepare the proximal tibia to receive a Journey II XR tibial baseplate.

The recall was initiated due to a higher than anticipated occurrence of bone fracture during the use of the instrument. The affected units were distributed to facilities in Oregon and Tennessee, as well as internationally to Japan.

Healthcare facilities should stop using the affected instruments and contact Smith & Nephew for instructions on return or replacement. The specific batch numbers affected are 17JGA0023, 17JGA0023A, 17JGA0023C, 17JGA0029, 17JGA0029A, 17JGA0029B, 17JGA0035A, 17JGA0035C, 17JGA0045B, 17JGA0045C, 17JGA0045D, and 17JGA0045R.

The recalled product

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.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
46

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: 17JGA0023
  • 17JGA0023A
  • 17JGA0023C
  • 17JGA0029
  • 17JGA0029A
  • 17JGA0029B
  • 17JGA0035A
  • 17JGA0035C
  • 17JGA0045B
  • 17JGA0045C
  • 17JGA0045D & 17JGA0045R

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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