Weitz & Luxenberg is no longer accepting Stryker Hip Implant Cases
Highlights of the FDA warning letter to Stryker Corp.
Regarding faulty
hip-implant devices
The warnings
stem from FDA inspections at Stryker’s New Jersey facility, located in Mahwah,
which produces hip implants, according to news reports.
Stryker's headquarters are located in Kalamazoo, Michigan.
Stryker manufactures ReUnion Plasma Spray Humeral Stem, Solar Plasma Purefix
HA Shoulder Stems, Trident PSL Acetabular Shells, Duracon Total Knee Modular
Femoral Component, hip implant components (Trident PSL HA Solid Black 52 MM,
Trident Hemispherical Cluster 50 MM), hip implants with ceramic bearing
components, and Global Modular Hip Stems.
Stryker has been warned for:
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.
Failure to establish and maintain procedures for monitoring and control in
line with federal statute.
Failure to establish and maintain procedures to control environmental
conditions that could have an adverse effect on their product (microbiological
hazards to the product).
Stryker had
responded to FDA on these issues on 8/1, 8/31, 9/28 and 11/2, which were
deemed to be inadequate by the FDA.
For potential clients, possible problems include poor fixation, "squeaky"
noises and implant failures (fractures, pain, wear particles and fragments).
The FDA also received complaints from 1/05-6/07 of improper seating which
resulted in bone fractures.
If you have questions about your Stryker hip implant, fill out the form
below.
FDA Warning Letter Highlights
FDA warning to Stryker Corp. about faulty hip-implant devices.
Highlights of the FDA letter to Stryker Corp. regarding hip implants.
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News & Warnings
Read the FDA Warning Letter re: Stryker Hip Implants.
FDA issues Warning Letter re: Stryker Hip Implants. Get the info here.