Lower riskMedical device recall · FDA · Published November 15, 2018
Howmedica Osteonics HydroSet XT Bone Cement Recall: Incorrect Expiry Date
Howmedica Osteonics recalls HydroSet XT Injectable HA Bone Cement with incorrect expiry date of 17-Dec-19 instead of 11-Aug-19. Affected units have lot numbers IC02565 and ICO2570.
“Howmedica Osteonics HydroSet XT Bone Cement Recall: Incorrect Expiry Date.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69463-howmedica-osteonics-hydroset-xt-bone-cement-recall-incorrect-expiry-date. Based on FDA recall #Z-0677-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0677-2019%22&limit=1).
The FDA announced on 2018-11-15 that Howmedica Osteonics Corp. voluntarily recalled HydroSet XT Injectable HA Bone Cement due to an incorrect expiry date. The company stated the correct expiration is 2019-08-11, not the printed 2019-12-17.
How to tell if you have it
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
UPC 07613327064261
Lot Numbers IC02565, ICO2570
The hazard
The recall addresses the incorrect expiry date of 17-Dec-19 on the product. The correct expiry date is 11-Aug-19.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since 2017-07-21. Other recent recalls of similar products include Cerapedics PearMatrix P-15 Bone Graft Recall (2025-12-29), Miach BEAR Implant Model 1000: Incorrect Expiration Date Risk (2025-12-31), and XTANT nanOss 3D Bone Graft Substitute Has Incorrect 5-Year Shelf Life Label (2026-03-09).
How to tell if you have this one
Check for lot numbers IC02565 or ICO2570 on the HydroSet XT Injectable HA Bone Cement packaging. The product is sterile and has a unique identifier (UDI) starting with (01)07613327064261.
Brand
Howmedica Osteonics
Product
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
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 II
Status
Terminated
Distribution
CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
Recall number
Product, codes & lots
Quantity
Z-0677-2019
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE; UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570
—
Z-0678-2019
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE; UDI - (01) 07613327064278 Lot Number: IC02595
—
Based on the official FDA remedy
What to do — step by step
Check Expiry Date
Verify the expiry date on the product label; the correct date is 11-Aug-19.
Where it went and when
Where it was distributed
Distributed in 19 states.
Listed by the agency
Not listed
FDA distribution: “CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Florida, Georgia, Iowa, Maine, Massachusetts, Michigan, Minnesota, New Hampshire, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0677-2019 (November 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0677-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.