Stryker Howmedica Osteonics product recalled over sterility concerns

Recall date

June 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement o…

Recall number

Z-2390-2016

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

Why it was recalled

It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants