Recall Z-0780-2020 ยท HRS Plate, Fixation, Bone
Stryker GmbH
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050
| Date | Dec 5, 2019 |
| Status | Terminated |
| Reason | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall Letter (PFA# 2219868) to US consignees on 5-Dec-2019 , letter states reason for recall, health risk and action to take: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the |
| Quantity | 433 (289 units U.S. / 144 units OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.