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Open, Classified

smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4

FDA Recall Z-1901-2024 · Posted 2024-05-24

Recalling FirmSmith & Nephew Inc
Recall StatusOpen, Classified
Product CodeLZO
Date Initiated2024-04-24
Product Quantity23 packages

Reason for Recall

Packaging contained the incorrect size of femoral head from what was displayed on the label.

Firm Action

The recalling firm issued letters on 4/24/2024 informing the consignees of the issue, the patient impact, risks to health, and the actions to be taken by the users. The actions included to locate and quarantine affected devices immediately and if they have been further distributed to other organizations, the consignee is requested to inform their consignees of this field action and provide a copy of the letter. A Customer Response form is to be completed and emailed or FAX'd back to the national Smith + Nephew agency/distributor. The product is to be returned to the national Smith + Nephew agency/distributor.

Root Cause

Process control

Distribution Pattern

International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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