FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
- Recall number
- Z-0677-2019
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
- Status
- Terminated
- Initiated
- 2018-11-15
- Posted
- not on file
- Terminated
- 2020-06-18
- Reason
- Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
- 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 Strykerortho6629@stericycle.com 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
- Quantity
- not on file
- Distribution
- CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
- Lot, serial or model codes
- UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570
- 510(k) numbers
- ["K161447"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28