Z-2090-2012Class II

Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland...

Name: Z-2090-2012 Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland...
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 Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica... 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-2090-2012
Classification: Class II
Status: Open, Classified
Initiated: 2012-04-30
Posted: 2012-07-26
Recalling firm: Howmedica Osteonics Corp
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 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
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: (NLS/NLV) - 23193 units and (SPT) - 20,743 units
Distribution: Nationwide Distribution
Product codes and lots: 510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2090-2012
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

K092561Class IIRejuvenate Modular StemHowmedica Osteonics Corp. / cleared 2009-10-20

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)