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Recall Observatory FDA recall evidence

Device product

Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103

Z-1509-2022

July 22, 2022

Class II

Product summary

Firm
Corin Ltd
Event
Event 90573
Status
Ongoing
Classification
Class II
Quantity
5 devices
Official record key
device-enforcement:Z-1509-2022

Official wording

Reason: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.

Code information: UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630

Distribution pattern: US Nationwide distribution in the states of OK, TX, FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.