FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products

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.
Brand
Stryker Howmedica Osteonics Corp.
UPC
Catalog Number: 1101-2100; Lot Codes: SZK01, SZK02, SZK03, SZK06 and SZL01.

Units Affected

273