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Recall Observatory FDA recall evidence

Device product

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

Z-1703-2018

April 16, 2018

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 79818
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1703-2018

Official wording

Reason: There may be burrs on the extraction hole threads.

Code information: Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181

Distribution pattern: The products were distributed to the following US states: FL, MO, and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There may be burrs on the extraction hole threads.