—#70887

Product

6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K873251, K894124
Affected lot / code info: Lot Code: 35323605

Why it was recalled

The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: nationwide

Timeline

Recall initiated: 2005-12-20
Posted by FDA: 2008-09-22
Terminated: 2008-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.