ModerateClass IIOngoing

FDA Devices recall · Reported August 1, 2012

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2089-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-2089-2012
Affected scope: 9003 units
Initiated: April 30, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Stryker Howmedica Osteonics Corp. recalled ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Irel… - a moderate-severity action.

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Irel… was recalled by Stryker Howmedica Osteonics Corp. in August 1, 2012. Reason: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Mo…. Check the official notice for the remedy. Verify recall #Z-2089-2012 with the FDA Devices before acting.

The recall

Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Mo….

Moderate
severity level: 9K units
affected scope: Class II
classification: August 1, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2089-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2089-2012
Date reported	August 1, 2012
Date initiated	April 30, 2012
Recalling firm	Stryker Howmedica Osteonics Corp.
Firm location	Mahwah, NJ
Affected scope	9003 units
Distribution	Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

9003 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2089-2012) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2089-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported August 1, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026