CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

HydroSet XT Injectable HA Bone Cement recalled by Howmedica Osteonics

Howmedica Osteonics is recalling HydroSet XT Injectable HA Bone Cement, distributed in 19 states. The recall was initiated on 15 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0677-2019
FDA event ID: 81641
Recalling firm: Howmedica Osteonics, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 Nov 2018
FDA classified: 22 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

15 Nov 2018	Recall initiated by company
22 Dec 2018	Classified by FDA	+37 days
2 Jan 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

Where it was distributed

CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV

Colorado Florida Georgia Iowa Massachusetts Maine Michigan Minnesota North Carolina North Dakota New Hampshire New York Pennsylvania South Carolina Tennessee Texas Virginia Wisconsin West Virginia

Questions about this recall

Is HydroSet XT Injectable HA Bone Cement recalled?

Yes. Howmedica Osteonics recalled HydroSet XT Injectable HA Bone Cement on 15 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0677-2019.

Why was it recalled?

Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

Which lots are affected?

UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570

Where was it sold?

CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Howmedica Osteonics

All 232

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
31 Dec 2025Device	CLASS II	The Stryker CranialMask Tracker is a single-use device recalled	Howmedica Osteonics	Device Malfunction	Nationwide
8 Oct 2025Device	CLASS II	Exeter V40 Stem No recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide