CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Journey II Bcs Constrained Articular Insert Size 5-6 Left recalled
Smith & Nephew is recalling Journey II Bcs Constrained Articular Insert Size 5-6 Left, distributed nationwide in the US. The recall was initiated on 27 Sep 2023 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-0158-2024
- FDA event ID
- 93156
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Sep 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 27 Sep 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +27 days |
| 1 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Where it was distributed
Worldwide distribution - US Nationwide and the country of Japan.
Questions about this recall
Why was it recalled?
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Which lots are affected?
UDI/DI 00885556176467, Batch Number 22BM17564
Where was it sold?
Worldwide distribution - US Nationwide and the country of 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
1 other product · FDA event 93156| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Journey Ii Bcs Articular Insert, Left Size recalled by Smith & Nephew | Smith & Nephew | Packaging Defects | Nationwide |
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