Stryker has recalled its ABG II Modular Neck and Stem because wear and corrosion may cause pain, swelling, tissue death, and the need for a revision. The ABG II is a modular neck and stem system that was designed to be used with Howmedica Osteonics’ femoral heads and acetabular (cup) components.
The ABG II was used with Howmedica Osteonics’ acetabular (cup) components, including V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, and UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.
Total hip replacements are typically recommended for the following uses:
- Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- To correct functional deformities;
- Revision procedures where other treatments or devices have failed; and,
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ABG II stem was approved by the FDA in November 2009. Stryker submitted the ABG II stem through the FDA’s 510(k) Premarket Notification Process. By submitting the ABG II stem this way, the Stryker stem did not have to undergo FDA testing. Instead, the stem was approved because it was substantially similar to the
Stryker Modular Hip System and the Rejuvenate Monolithic Hip Size 4 Stem.