—#83619

Product

Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

FDA product code: IQO — Device, Prosthesis Alignment
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.

Why it was recalled

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Orthopaedics issued an "Important Product Removal" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax. For further information, contact Stryker Orthopaedics at 1-201-831-5825.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-09-11
Posted by FDA: 2009-08-26
Terminated: 2009-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.