Recall Z-0435-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Merete Medical GmbH
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
| Date | Sep 18, 2020 |
| Status | Terminated |
| Reason | Product may be mislabeled. |
| Root cause | Process design |
| Action | The recalling firm contacted their importer via email to notify them of the recall. The importer contacted impacted distributors by phone to notify them of the incident and ask that product be shipped back. Customers were provided with overnight shipping labels to ship the product back to the importer. The recalling firm will reconcile returned product quantities against shipping records to ensure all product is returned. |
| Quantity | 306 units |
| Distribution | Product was distributed in US - CA, IL, MD, OH, and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101939 | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM Merete Medical GmbH, Oct 7, 2010 |