Devices

Device Recall ReUnion

Model / Serial
Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
One hospital in Akron OH and 12 Stryker branches/agencies
Product Description
ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. || Distal Diameter - 7 to 15mm; || Hydroxylapatite coated; || Titanium Plasma Spray; || Howmedica Osteonics Corp.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall ReUnion

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

One device with a similar name

Learn more about the data here

Device Recall Reunion HA Fracture Stem

Model / Serial
R5351-4507 REUNION HA FRACTURE STEM 7MM T2T72836-J, R5351-4508 ReUnion HA Fracture Stem 8MM T2N71522-I, R5351-4508 ReUnion HA Fracture Stem 8MM T2T72422-C and R5351-4509 REUNION HA FRACTURE STEM 9MM T2N71523-G
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
Reunion HA Fracture Stem || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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