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Recall Observatory FDA recall evidence

Device product

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

Z-0651-2022

December 30, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 89520
Status
Terminated
Classification
Class II
Quantity
59 devices
Official record key
device-enforcement:Z-0651-2022

Official wording

Reason: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Code information: GTIN: 04546540509048; Lot G7900236

Distribution pattern: The product was distributed to the following US states: MI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.