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Open, Classified

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.

FDA Recall Z-2334-2020 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeMBL
Date Initiated2020-04-22
Product Quantity4172 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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