Recall Z-1325-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Nuvasive Specialized Orthopedics Inc
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
| Date | Mar 30, 2021 (initiated Feb 12, 2021) |
| Status | Open, Classified |
| Reason | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. |
| Root cause | Under Investigation by firm |
| Action | On 02/12/2021, the firm sent via email an "URGENT FIELD SAFETY NOTICE" that informed customers that There have been several reports of adverse events potentially related to biological safety in one of the device systems, which are currently under investigation. The events include reports of pain and bony abnormalities at the interface between the telescoping nail segments. The Recalling Firm is informing its customers that the affected devices are not indicated for use in individuals younger than 18 years of age and instructing/informing them: -That an Recalling Firm representative will be co |
| Quantity | 40 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Swede |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192181 | PRECICE Plating System Nuvasive Specialized Orthopedics, Inc., Nov 7, 2019 |