Tobra Bone Cement Recall for Missing Turkish Instructions
Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses, injuries, or deaths. The hazard is a documentation issue—missing Turkish translation in Instructions for Use—not a defect in the medical device itself. The actual content is accurate, limiting severity to a communication/labeling concern.
Plain-English summary
Howmedica Osteonics Corp. is recalling Tobra Full Dose CE Antibiotic Simplex P, a bone cement used in orthopaedic surgery to fix prostheses to living bone. The recall encompasses 20 units that were distributed internationally, primarily to Turkey.
The Instructions for Use included in the product packaging lacks a Turkish language translation. All content within the instructions is accurate and complete.
Patients and healthcare providers who received this product should consult the available Instructions for Use or contact the manufacturer for translation assistance. Since the instruction content itself is medically accurate, the primary concern is ensuring proper communication regarding proper use of the device.
The recalled product
- Product
- Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- which with expiration date on/after October 28
- 2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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