Recall Z-0677-2019 ยท MQV Filler, Bone Void, Calcium Compound
Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
| Date | Nov 15, 2018 |
| Status | Terminated |
| 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 follow |
| Distribution | CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161447 | HydroSet XT Orthovita, Inc., Oct 6, 2016 |