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Recall Observatory FDA recall evidence

Device product

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Z-0158-2024

September 27, 2023

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 93156
Status
Ongoing
Classification
Class II
Quantity
29 units
Official record key
device-enforcement:Z-0158-2024

Official wording

Reason: 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.

Code information: UDI/DI 00885556176467, Batch Number 22BM17564

Distribution pattern: Worldwide distribution - US Nationwide and the country of Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.