Class 2 Device Recall The PRECICE System

• Date Initiated by Firm: February 12, 2021
• Date Posted: March 30, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1325-2021
• Recall Event ID: 87352
• 510(K)Number: K192181
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
• Code Information: All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 00887517021915 LP4.5-DLF30 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 0-Hole; 00887517021908 LP4.5-DLF31 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 1-Hole; 00887517021892 LP4.5-DLF32 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 2-Hole; 00887517021885 LP4.5-DLF3B PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, Bump; 00887517021878 LP4.5-DLF40 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 0-Hole; 00887517021861 LP4.5-DLF41 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 1-Hole; 00887517021854 LP4.5-DLF42 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 2-Hole; 00887517021847 LP4.5-DLF4B PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, Bump; 00887517021830 LP4.5-DRF30 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 0-Hole; 00887517021823 LP4.5-DRF31 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 1-Hole; 00887517021816 LP4.5-DRF32 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 2-Hole; 00887517021809 LP4.5-DRF3B PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, Bump; 00887517021793 LP4.5-DRF40 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole; 00887517021786 LP4.5-DRF41 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 1-Hole; 00887517021779 LP4.5-DRF42 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 2-Hole; 00887517021762 LP4.5-DRF4B PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump; 00887517021755 LP4.5-MLT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021748 LP4.5-MLT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021731 LP4.5-MLT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021724 LP4.5-MLT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, Bump; 00887517021717 LP4.5-MLT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021700 LP4.5-MLT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021694 LP4.5-MLT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021687 LP4.5-MLT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, Bump; 00887517021670 LP4.5-MRT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021663 LP4.5-MRT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021656 LP4.5-MRT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021649 LP4.5-MRT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, Bump; 00887517021632 LP4.5-MRT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021625 LP4.5-MRT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021618 LP4.5-MRT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021601 LP4.5-MRT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump; 00887517021595 LP4.5-PLF30 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 0-Hole; 00887517021588 LP4.5-PLF31 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 1-Hole; 00887517021571 LP4.5-PLF32 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 2-Hole; 00887517021564 LP4.5-PLF3B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, Bump; 00887517021557 LP4.5-PLF40 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 0-Hole; 00887517021540 LP4.5-PLF41 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 1-Hole; 00887517021533 LP4.5-PLF42 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 2-Hole; 00887517021526 LP4.5-PLF4B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, Bump; 00887517021519 LP4.5-PLT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021502 LP4.5-PLT31 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021496 LP4.5-PLT32 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021489 LP4.5-PLT3B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, Bump; 00887517021472 LP4.5-PLT40 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021465 LP4.5-PLT41 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021458 LP4.5-PLT42 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021441 LP4.5-PLT4B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, Bump; 00887517021434 LP4.5-PRF30 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 0-Hole; 00887517021427 LP4.5-PRF31 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 1-Hole; 00887517021410 LP4.5-PRF32 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 2-Hole; 00887517021403 LP4.5-PRF3B PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, Bump; 00887517021397 LP4.5-PRF40 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 0-Hole; 00887517021380 LP4.5-PRF41 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 1-Hole; 00887517021373 LP4.5-PRF42 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 2-Hole; 00887517021366 LP4.5-PRF4B PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, Bump; 00887517021359 LP4.5-PRT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021342 LP4.5-PRT31 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021335 LP4.5-PRT32 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021328 LP4.5-PRT3B PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, Bump; 00887517021311 LP4.5-PRT40 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021304 LP4.5-PRT41 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021298 LP4.5-PRT42 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021281 LP4.5-PRT4B PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, Bump; 00887517021274 LP4.5-SLF30 PRECICE Plate 4.5mm Shaft Plate, Left, 35mm, Long Magnet
• Recalling Firm/ Manufacturer: Nuvasive Specialized Orthopedics Inc; 101 Enterprise Ste 100; Aliso Viejo CA 92656-2604
• For Additional Information Contact: Patrick Yrigoyen; 858-336-3421
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 contacted their office or they will be provided instructions for returning the affected product. -To not implant the affected devices until further notice. -To review, complete, sign and return the Consignee Confirmation Form by scanning and emailing the form to FSNprecice@nuvasive.com. -The affected devices will not be available until further notice. -Prophylactic removal of functioning devices is not recommended. Instead, any treatment decisions should be made by the physician in consultation with the patient and/or family. -For any patients, assessment of any symptoms, via consultation, and radiography should be made to determine if pain and abnormal bony changes might be present, as described above. --- If so, then clinical care decisions should be made at the discretion of the healthcare team, in consultation with the patient and any other relevant decision makers. -If a patient has been previously implanted with the listed device and was under the age of 18, consultation may be warranted, at the discretion of the provider. -If a patient has been previously implanted with a listed device and is pregnant, becomes pregnant, or intends to become pregnant, consultation may be warranted, at the discretion of the provider. -Forward this notice to anyone in your facility that needs to be informed. -Direct any additional manufacturer inquiries to FSNprecice@nuvasive.co
• Quantity in Commerce: 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, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HSB