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Recall Observatory FDA recall evidence

Device product

DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

Z-0992-2018

June 30, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79242
Status
Terminated
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-0992-2018

Official wording

Reason: Product may contain the presence of melted sterile packaging upon opening.

Code information: part number: 650-1162 lot number: 2016030466

Distribution pattern: US in the state of Texas

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product may contain the presence of melted sterile packaging upon opening.