Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Recall Z-0975-2014 · Posted 2014-02-12
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKKY
Date Initiated2013-12-06
Date Terminated2015-05-06
Product Quantityone unit
Reason for Recall
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Firm Action
Stryker Orthopaedics sent Urgent Medical Device Recall Notification letters/Product Recall Acknowledgement Forms dated 12/6/2013 to US branch/agency. surgeons, hospital risk managers, and sales representatives.
Root Cause
Labeling Change Control
Distribution Pattern
Distributed in PA.
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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