Stryker Howmedica Osteonics is the orthopaedic implant division of Stryker Corporation. Around 20 million Americans have osteoarthritis, which often occurs in the hip joint. When the cartilage has worn thin because of it, a hip replacement surgery may be necessary. Stryker Howmedica Osteonics has a range of primary femoral hip components that are used for surgical implants.

In September 2001, the FDA announced a hip implant recall due to a potential fracture problem. The French manufacturer St. Gobain Desmarquest recalled the zirconia ceramic femoral head component in August 2001 after noticing it was fracturing at a higher rate than expected in some patients just 13-27 months after being implanted. At the time of the recall, other medical manufacturers, including Stryker Howmedica Osteonics, used the French medical device products.

The U.S. companies had estimated the hip implants with zirconia ceramic femoral heads are used in less than 6% of the hip implant procedures in the U.S., with an estimated 150,000-200,000 hip implants performed every year in the U.S. If affected Stryker Howmedica implants were used, the patient would experience sudden pain in the implanted hip joint. In some instances, the pain was preceded by a "pop" noise from the hip.

Since each additional operation increases the risk of the hip implant not lasting, the affected Stryker Howmedica implants threatened the long term well being of patients. The 2001 hip replacement recall affecting Stryker Howmedica was the second large hip replacement recall within a couple years. Even though not every one of the recalled Howmedica hips was believed to be problematic, the FDA medical officer had advised all patients to move on the side of caution since the complications could be significant.

The hip implant recall affected Stryker Howmedica zirconia ceramic femoral heads that had been manufactured since January 1998. Hip replacement surgery is a major procedure that involves hospitalization, rehabilitation, a large amount of discomfort, and relearning how to walk with the implanted hip, so re-operation can be devastating news to a patient. The FDA recommended the Howmedica hip implant patients to contact their physicians since there was an absence of tests available to predict which recalled models would fail.

After the first major hip replacement recall involving Sulzer Orthopedics, lawsuits were filed due to the devastating effects it left on some patients. In 2000, a National Institutes of Health panel reported that more studies needed to be performed on what happens to medical devices after they are implanted into patients. The hip replacement recall involving Howmedica and the other companies using the St. Gobain manufactured components was another indication that improvements in patient safety can always be made.