Z-2089-2012Class II

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill...

Name: Z-2089-2012 ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-04-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-04-30 / Open, Classified / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland... on 2012-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2089-2012
Classification: Class II
Status: Open, Classified
Initiated: 2012-04-30
Posted: 2012-07-26
Recalling firm: Howmedica Osteonics Corp
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 strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an "URGENT PRODUCT CORRECTION" letter dated April 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Product Correction Acknowledgment Form for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-831-5970 for questions regarding this notice. Stryker sent and "Urgent Update Product Recall" Letter dated January 3, 2013 to all affected customers. The new letter includes updated corrective actions for patients. Another letter was sent out on 7/25/2014.
Quantity in commerce: 9003 units
Distribution: Nationwide Distribution
Product codes and lots: 510 K092406 all lots (4845-4XXX and NLS/NLV)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2089-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2089-2012	Class II	Ongoing	Voluntary: Firm initiated	2012-08-01	2012-07-26
Z-2090-2012	Class II	Ongoing	Voluntary: Firm initiated	2012-08-01	2012-07-26

Product code MEH

K092406Class IIAbg II Modular Hip StemHowmedica Osteonics Corp. / cleared 2009-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)