Recall Z-2424-2019 ยท HRX Arthroscope
Stryker GmbH
Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
| Date | Jul 25, 2019 |
| Status | Terminated |
| Reason | The seal integrity of the sterile bag containing the kits may be compromised. |
| Root cause | Packaging |
| Action | The firm, Stryker, sent an "UPDATE URGENT MEDICAL DEVICE RECALL" notification letters dated 7/25/19 were to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 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 |
| Quantity | 259 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS Instratek, Inc., Dec 12, 1994 |