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Terminated

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 Recall Z-0793-2010 · Posted 2010-02-17

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHTO
Date Initiated2005-08-08
Date Terminated2010-02-18
Product Quantity273

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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