Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
FDA Recall Z-0194-2012 · Posted 2011-11-16
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2011-06-03
Date Terminated2013-11-13
Product Quantity13,263 units
Reason for Recall
Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
Firm Action
The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069.
If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Root Cause
Labeling False and Misleading
Distribution Pattern
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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