CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
Journey Ii XR Tibial Posterior Keel Punch Sz recalled by Smith & Nephew
Smith & Nephew is recalling Journey Ii XR Tibial Posterior Keel Punch Sz 1-2, distributed in Oregon, Tennessee. The recall was initiated on 10 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1042-2019
- FDA event ID
- 81766
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2018
- FDA classified
- 22 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 10 Dec 2018 | Recall initiated by company | |
| 22 Mar 2019 | Classified by FDA | +102 days |
| 3 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Product as listed by the FDA
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.
Where it was distributed
US Distribution to OR and TN; and Internationally to: Japan.
Questions about this recall
Why was it recalled?
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Which lots are affected?
Batch Numbers: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R
Where was it sold?
US Distribution to OR and TN; and Internationally to: Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 81766This product is part of a recall event; the main page for the event is Journey Ii XR Tibial Posterior Keel Punch Sz recalled by Smith & Nephew.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Journey Ii XR Tibial Posterior Keel Punch Sz recalled by Smith & Nephew | Smith & Nephew | Other | OR, TN | |
| CLASS II | Journey Ii XR Tibial Posterior Keel Punch Sz recalled by Smith & Nephew | Smith & Nephew | Other | OR, TN | |
| CLASS II | Journey Ii XR Tibial Posterior Keel Punch Sz recalled by Smith & Nephew | Smith & Nephew | Other | OR, TN |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |