Devices

Omnifit M/S PSL Shell

Model / Serial
Catalog number 2017-0058, Lot # 4N3046, 4S3019, 5L3029, 5N3062, 7E3018, 7K3003, 7K3003A, 7K3004, 7M3052, 7M3052A, 8M3024 8M3024A, MER9DP, MER9EE, MHMW56.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA including states of: AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA , and WI; and countries including: China, Hong Kong and Korea.
Product Description
Omnifit M/S PSL Shell 58 MM; || Stryker Orthopaedics, || Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Omnifit M/S PSL Shell

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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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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