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Devices
Device Recall Solar Shoulder Humeral Stem
Model / Serial
CAT. NO.5351-4103, SHOULDER - HUMERAL STEM 7mm , LOT CODE XKRMHE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm, LOT CODE 8ETMJE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm LOT CODE 8EYMJE, CAT. NO. 5351-4107 SHOULDER - HUMERAL STEM 11mm LOT CODE V45MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV3MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV4MKE, CAT. NO. 5351-4109 SHOULDER - HUMERAL STEM 13mm LOT CODE VWHMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE HTXMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE T7TMKE, CAT. NO. 5351-4113 SHOULDER - HUMERAL STEM 17mm LOT CODE KKHMKE and CAT. NO. 5351-4205 SHOULDER - HUMERAL 200mmX9mm LOT CODE MT9MKE
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Product Description
Solar Shoulder Humeral Stem || These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall Solar Shoulder Humeral Stem
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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