Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the Recalled by Howmedica Osteonics Corp. Due to Instructions for Use (IFU) included in the packaging...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Howmedica Osteonics Corp. directly.
Affected Products
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Quantity: 20 units
Why Was This Recalled?
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.
Where Was This Sold?
International distribution in the country of Turkey.
About Howmedica Osteonics Corp.
Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report