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.
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: 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
- Affected units
- 2,085
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.
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · missing translation
See all →- ModerateDefibtech Automated External Defibrillators Model DDU-2300 Recalled
FDA (Devices) · 2025-05-07
- ModerateAutomated External Defibrillator Model DDU-2450 Missing Italian Translation
FDA (Devices) · 2025-05-07
- ModerateTobra Bone Cement Recall for Missing Turkish Instructions
FDA (Devices) · 2022-12-28
Similar recalls
- ModerateHowmedica Recalls HydroSet XT Injectable HA Bone Cement Due to Incorrect Expiry Date
FDA (Devices) · 2019-01-02
- ModerateHowmedica Recalls HydroSet XT Injectable HA Bone Cement Due to Expiry Error
FDA (Devices) · 2019-01-02
- ModerateHowmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
FDA (Devices) · 2018-05-02
- ModerateBiomet Cobalt HV Bone Cement Recalled for Packaging Seal Loss
FDA (Devices) · 2017-11-15
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- ModerateHowmedica Custom Implant System Recalled for Missing Instructions
FDA (Devices) · 2018-08-08