CLASS II ONGOING Device recall · Reported 1 Aug 2012 · FDA Enforcement Report
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp recalled
Stryker Howmedica Osteonics is recalling ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp, distributed nationwide in the US. The recall was initiated on 30 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2089-2012
- FDA event ID
- 62456
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2012
- FDA classified
- 26 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 Apr 2012 | Recall initiated by company | |
| 26 Jul 2012 | Classified by FDA | +87 days |
| 1 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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
Which lots are affected?
510 K092406 all lots (4845-4XXX and NLS/NLV)
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 62456| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rejuvenate Modular Stems Stryker Ireland Carrigtwohill recalled | Stryker Howmedica Osteonics | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) recalled | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
| Device | CLASS II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled | Stryker Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled | Stryker Howmedica Osteonics | Other | NJ |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |