Lower riskMedical device recall · FDA · Published November 7, 2022
Howmedica Full Dose CE Simplex P Bone Cement: Turkish IFU Missing
Howmedica recalls Full Dose CE Simplex P Single Bone Cement due to missing Turkish language instructions. All content in instructions is accurate but Turkish translation is absent.
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.
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Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer
Howmedica is recalling Full Dose CE Simplex P Single Bone Cement because the Turkish language instructions for use are missing. This could affect patients who need the product in Turkish-speaking regions, though the rest of the instructions are accurate. Read more at govinfonow.com/recall/59489-howmedica-full-dose-ce-simplex-p-bone-cement-turkish-ifu.
“Howmedica Full Dose CE Simplex P Bone Cement: Turkish IFU Missing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59489-howmedica-full-dose-ce-simplex-p-bone-cement-turkish-ifu. Based on FDA recall #Z-0736-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2023%22&limit=1).
The FDA announced on November 7, 2022, that Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the Instructions for Use are missing a Turkish translation. The agency classified the recall as Class III.
How to tell if you have it
Brand: Howmedica
Product: Full Dose CE Simplex P Single Bone Cement
The Instructions for Use 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.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Howmedica SCORPIO Mobile Bearing PCS Recall (July 30, 2026), Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026).
How to tell if you have this one
Check for the product name 'Full Dose CE Simplex P Single Bone Cement' with catalog number 6191-0-001. The product was sold from September 16, 2021, onward with expiration dates on or after that date.
Brand
Howmedica
Product
Full Dose CE Simplex P Single Bone Cement
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Ongoing
Distribution
International distribution in the country of Turkey.
Recall number
Product, codes & lots
Quantity
Z-0736-2023
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001; UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021.
2085 units
Z-0737-2023
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001; 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
20 units
Based on the official FDA remedy
What to do — step by step
Check Instructions
Verify if the product includes Turkish language instructions for use (IFU).
How this recall unfolded
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0736-2023 (November 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0736-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.