Bone Cement Recall: Missing Turkish Language Instructions for Use
Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.
What this means for you
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: This is an FDA Class III recall involving a labeling issue: missing translation of product instructions. No reported harm, injuries, or deaths. The product content is accurate; only the language translation is absent. This meets the criteria for Moderate severity as a minor labeling error.
Plain-English summary
Full Dose CE Simplex P Single Bone Cement, a medical device used for fixing prostheses to bone in orthopedic procedures, is being recalled by Howmedica Osteonics Corp. This recall involves 2,085 units distributed internationally to Turkey.
The Instructions for Use (IFU) packaged with the product does not include a Turkish language translation. Although all medical and technical content within the IFU is accurate and correct, the missing Turkish translation makes the instructions inaccessible to Turkish-speaking users in the affected market.
Affected product can be identified by UDI (Unique Device Identifier) P/N 6191-0-001 (GTIN: 07613327128772). All lots manufactured under Revision AB with expiration dates on or after September 16, 2021 are included in this recall.
The recalled product
- Product
- Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- missing-translation
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)
- with Exp. Date on/after September 16
- 2021.
Distribution
Distribution scope not specified by the agency.
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