Stryker Howmedica Osteonics Corp.: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an

Agency Publication Date: July 26, 2012

Affected Products

Product: ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue stren

510 K092406 all lots (4845-4XXX and NLS/NLV)

Product: Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengt

510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62456

Status: Active

Manufacturer: Stryker Howmedica Osteonics Corp.

Manufactured In: United States

Units Affected: 2 products (9003 units; (NLS/NLV) - 23193 units and (SPT) - 20,743 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

510 K092406 all lots (4845-4XXX and NLS/NLV)

510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)