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Recall Observatory FDA recall evidence

Device product

GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

Z-1996-2013

July 08, 2013

Class II

Product summary

Firm
Smith & Nephew Inc
Event
Event 65738
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1996-2013

Official wording

Reason: The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

Code information: Lot Number 12LM03798

Distribution pattern: International only: Germany, France, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).