Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized Representative in Europe: Stryker France, Cedex France. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
FDA Recall Z-0884-2009 · Posted 2009-01-26
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2008-11-21
Date Terminated2012-06-25
Product Quantity4
Reason for Recall
Stryker became aware of a lot for lot mix up.
Firm Action
Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.
Root Cause
Labeling mix-ups
Distribution Pattern
Class II Recall - Nationwide 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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