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Terminated

Restoration Modular Hip System; Proximal Cone Body; 21 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

FDA Recall Z-2160-2009 · Posted 2009-09-14

Recall StatusTerminated
Product CodeLZO
Date Initiated2009-06-26
Date Terminated2010-07-27
Product Quantity203 - all varieties

Reason for Recall

The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St

Firm Action

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution

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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