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Recall Observatory FDA recall evidence

Device product

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

Z-1496-2014

April 01, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 67795
Status
Terminated
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-1496-2014

Official wording

Reason: The shell was missing the locking ring.

Code information: 00-6202-060-22; lot 62490588

Distribution pattern: Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The shell was missing the locking ring.