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Recall Observatory FDA recall evidence

Device product

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Z-2949-2018

July 18, 2018

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 80666
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2949-2018

Official wording

Reason: This unit may be missing the screw/collet Assembly

Code information: Lot: C2KJ24, GTIN: 10603295234135

Distribution pattern: The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This unit may be missing the screw/collet Assembly