Aliso Viejo, CA, United States
Nuvasive Specialized Orthopedics Inc recalls
7 recalls recorded since 2018, most recently on 30 September 2024. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)7
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 September 2024
- Reason
- Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
- Distribution
- U.S distribution to states of: FL and NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0500-2025
- Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Fem
Ongoing Class II Medical devices
- Recall started
- 1 November 2022
- Reason
- During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
- Distribution
- Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0559-2023
- NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Ro
Ongoing Class II Medical devices
- Recall started
- 29 October 2021
- Reason
- The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Argentina, Australia, Austria, Belgium, Canada, Colombia, Chile, Cyprus, Denmark,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0319-2022
- NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005
Ongoing Class II Medical devices
- Recall started
- 12 February 2021
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1325-2021, Z-1323-2021, Z-1324-2021
- PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
- PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
- Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Ongoing Class II Medical devices
- Recall started
- 12 February 2021
- Reason
- Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
- Distribution
- Worldwide distribution, including U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1350-2021, Z-1351-2021, Z-1349-2021
- NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod
- NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8
- NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm;
Ongoing Class II Medical devices
- Recall started
- 24 July 2020
- Reason
- During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
- Distribution
- Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0069-2021
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instru
Ongoing Class II Medical devices
- Recall started
- 25 June 2019
- Reason
- Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0528-2022
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.