Devices

Device Recall Restoration ADM System X3 Acetabular Insert

Model / Serial
Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64) All Lots K093644
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide distribution.
Product Description
Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France || The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall Restoration ADM System X3 Acetabular Insert

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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