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Open, Classified

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

FDA Recall Z-2335-2020 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeMBL
Date Initiated2020-04-22
Product Quantity1766 devices

Reason for Recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

Firm Action

The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070756SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc. · 2007-06-06

Official Source

View FDA Recall →

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

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