Stryker responds to recent FDA warning letter, recalls certain acetabular cups

An FDA inspection found violations in the methods used for manufacturing, packing, storage or installation of certain devices.

Stryker has initiated a voluntary recall of its Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork, Ireland, facility, the company announced.

The action follows an internal investigation that Stryker conducted into a deviation from its internal specifications and processes for manufacturing the devices at the facility. The investigation found that all Trident Acetabular products manufactured at the facility did meet all U.S. and international performance standards for sterility and biocompatibility. However, results from that testing indicated that the level of manufacturing residuals in some cases exceeded the company's internal acceptance criteria, according to a press release from Stryker.

"It is important to note this in no way impacts the product's sterility, nor product conformance to U.S. and international biocompatibility standards," the release stated. "Medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products. In fact, independent clinical evidence confirms that the performance of these cups compares very favorably with other high performing acetabular devices."

Trident Acetabular Cups manufactured at Stryker's Mahwah, N.J., facility are not included in the recall, the release said.

Stryker had initiated its internal investigation in response to a Warning Letter it received from the U.S. Food and Drug Administration in November 2007, which the FDA made available on its Web site on January 15.

The agency issued the warning letter after an inspection by an FDA official found that the devices were adulterated "in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements," according to the warning letter.

In particular, the FDA cited the following violations:

Failure to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, and verifying or validating the corrective and preventive action to ensure that such action is effective.
Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
Failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality.

Stryker stated in its press release that it is taking the situation seriously and has been cooperating fully with the FDA to address questions related to the FDA's observations of Stryker's internal process specifications.

It noted that the company does not believe there is any clinical evidence to indicate that the products mentioned in the warning letter present a safety issue to patients.

As a result of the voluntary recall, Stryker anticipates some short-term supply disruption.

It noted that it has now validated the manufacturing process for the affected products at its Cork, Ireland, facility, and product shipments have resumed. Also, the company has increased production at the Mahwah, N.J. and the Cork, Ireland, facilities.

For more information:
U.S. Food and Drug Administration Warning letter 08-NWJ-03 to Stryker Orthopaedics Corp. Nov. 28, 2007. Available at: http://www.fda.gov/foi/warning_letters/s6627c.htm.