Z-0677-2019Class II

HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

Name: Z-0677-2019 HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Creator: Howmedica Osteonics Corp.
Published: 2018-11-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-11-15 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE on 2018-11-15. FDA classified it as Class II and gives the reason as "Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0677-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-15
Posted: 2018-12-22
Terminated: 2020-06-18
Recalling firm: Howmedica Osteonics Corp
Product: HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On November 15, 2018, Stryker issued Urgent Medical Device Recall notices to customers via Fedex. Customers were advised to take the following actions: 1. Inform users of the medical device recall and forward a copy of the notice to all those individuals who need to be aware within the organization. 2. Examine inventory to identify impacted HydroSet kits. 3. Immediately quarantine any affected product. 4. Complete and return the Business Reply Form via email to [email protected] or via fax to 1-888-345-3845. 5. Return all affected product available at your location to the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07431, Ref. PFA 1878253
Distribution: CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
Product codes and lots: UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0677-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0678-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code MQV

K161447Class IIHydroSet XTOrthovita, Inc. / cleared 2016-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)