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Device Recall Stryker CMF Customized Implant Kit
Model / Serial
510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed in PA.
Product Description
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.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall Stryker CMF Customized Implant Kit
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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