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Recall Observatory FDA recall evidence

Device product

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Z-2267-2018

May 11, 2018

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 80126
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2267-2018

Official wording

Reason: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US

Code information: (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246

Distribution pattern: OH, TX, CO, TN, MI, PA, NJ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US