Recall Z-0781-2020 ยท JEC Component, Traction, Invasive
Stryker GmbH
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric frac
| Date | Nov 21, 2019 |
| Status | Terminated |
| Reason | Pin To Rod Coupling could not clamp the pin and rod as intended |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall - PFA 2227937 letter on November 21, 2019 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter was also issued at the country level. The letter states reason for recall, health risk and action to take: Actions Needed: 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 de |
| Distribution | Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX Stryker Corp., Jan 14, 2011 |