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Terminated

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

FDA Recall Z-2810-2015 · Posted 2015-09-23

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2015-06-25
Date Terminated2017-08-30
Product Quantity16 units

Reason for Recall

it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

Firm Action

Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033716TRIDENT ACETABULAR SYSTEMHowmedica Osteonics Corp. · 2005-02-10

Official Source

View FDA Recall →

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

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