Howmedica Osteonics Corp.: Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

Hazard

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

Details from the source

Reason for recall: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate. Distribution: International distribution in the country of Turkey. Quantity: 20 units Lot/code info: UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot# GTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, which with expiration date on/after October 28, 2021

UPC codes

07613327128741

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.