HydroSet XT recallZ-0678-2019 · Howmedica Osteonics Corp. · initiated Nov 15, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
FDA root cause category: Labeling mix-ups
What the company is doing
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
Recall details
- Recall number
- Z-0678-2019
- Status
- Terminated
- Initiated by the company
- Nov 15, 2018
- Recalling firm
- Howmedica Osteonics Corp.
- Product code
- MQV
- FDA submissions
- K161447
- Distribution
- CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
Product description
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Code information (models, lots, serial numbers)
UDI - (01) 07613327064278 Lot Number: IC02595
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroSet XT 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81641).
- Z-0677-2019 · TerminatedHydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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