—#74720

Product

Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 1101-2100; Lot Codes: SZK01, SZK02, SZK03, SZK06 and SZL01.

Why it was recalled

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.

Timeline

Recall initiated: 2005-08-08
Posted by FDA: 2010-02-17
Terminated: 2010-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.