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Recall Observatory FDA recall evidence

Device product

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

Z-1239-2018

January 24, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79400
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1239-2018

Official wording

Reason: One lot of humeral stem implants do not include the humeral bushing components.

Code information: Lot Number: 63694912

Distribution pattern: Distributed in China and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of humeral stem implants do not include the humeral bushing components.