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Devices
Device Recall Stryker Sigmoid Notch, Radial Plate
Model / Serial
Part Number: 390-0305 (Sigmoid Notch Radial Stem, Small) - Lot #'s 18362, 22834401 and 23852901; Part Number: 390-0307 (Sigmoid Notch Radial Stem, Large) - Lot #'s 18728, 18815, 18816, 18817, 23834501 and 23853001
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution.
Product Description
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall Stryker Sigmoid Notch, Radial Plate
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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