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Terminated

SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

FDA Recall Z-0730-2019 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2019-01-07
Date Terminated2020-09-17
Product Quantity72 units

Reason for Recall

The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

Firm Action

The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product.

Root Cause

Process control

Distribution Pattern

NY, TN, Germany, Italy, Great Britain, Singapore

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc. · 2013-06-28

Official Source

View FDA Recall →

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

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