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Terminated

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

FDA Recall Z-2267-2018 · Posted 2018-05-21

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeNXT
Date Initiated2018-05-11
Date Terminated2019-04-05
Product Quantity2 units

Reason for Recall

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

Firm Action

The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.

Root Cause

Process control

Distribution Pattern

OH, TX, CO, TN, MI, PA, NJ

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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