Recall Z-2401-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S
| Date | Apr 27, 2018 |
| Status | Terminated |
| Reason | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. |
| Root cause | Employee error |
| Action | Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 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. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all requir |
| Distribution | The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003018 | TITAN TIBIAL NAIL Howmedica Osteonics Corp., Dec 15, 2000 |