Recall Z-2386-2020 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
| Date | Jun 16, 2020 (initiated May 7, 2020) |
| Status | Terminated |
| Reason | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| Root cause | Process control |
| Action | Stryker issued Urgent Medical Device Recall (UMDR) - PFA 2365134 letter on May 7, 2020 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 will also be issued at the country level The letter states reason for recall, heath risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any |
| Quantity | OUS 121 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032244 | GAMMA 3 NAIL SYSTEM Howmedica Osteonics Corp., Aug 8, 2003 |