Reported Apr 14, 2021 · Ongoing
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma…
Nuvasive Specialized Orthopedics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nuvasive Specialized Orthopedics Inc · 101 Enterprise Ste 100 · Aliso Viejo, CA · 92656-2604
Is this the product you have?
- 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, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra
- Lot codes and dates
- All Lots manufactured between April 2015 to February 2021. PRECICE
- Unyte Product Codes (for Humerus)Trauma intramedullary rod, humerus, 8.5
- mm diameter
CDH8.5-20L165CDH8.5-20L180CDH8.5-30L195CDH8.5-50L210CDH8.5-50M225CDH8.5-50M240CDH8.5-80M255CDH8.5-80M270CDH8.5-80M285CDH8.5-80M300end cap
- for trauma intramedullary humeral nail
HEC1-000HEC2-000HEC3-000HEC4-000HEC5-000
- Locking screws
LSB3-020LSB3-025LSB3-030LSB3-035LSB3-040LSB3-045LSB3-050LSB3-055LSB3-060LSB3-065LSB3-070LSB3-075LSB5-020LSB5-025LSB5-030LSB5-035LSB5-040LSB5-045LSB5-050LSB5-055LSB5-060LSB5-065LSB5-070LSB5-075LSC5-020LSC5-025LSC5-030LSC5-035LSC5-040LSC5-045LSC5-050LSC5-055LSC5-060LSC5-065LSC5-070LSC5-075LSC5-080LSC5-085LSC5-090LSC5-095LSC5-100
- GTIN Number (for Humerus)
0081225802273000812258022747008122580227540081225802276100812258022778008122580227850081225802279200812258022808008122580228150081225802282200812258028121008122580281380081225802814500812258028152008122580281690081225802133700812258021344008122580213510081225802136800812258021375008122580213820081225802139900812258021405008122580214120088751793623300887517936240008875179362570085671900288600856719002893008567190029090085671900291600856719002923008567190029300085671900294700856719002954008567190029610085671900297800856719002985008567190029920081225802151100812258021528008122580215350081225802154200812258021559008122580215660081225802157300812258021580008122580215970081225802160300812258021610008122580216270088751700103000887517001047008875170010540088751700106100887517001078
- Precice Unyte Product Codes (for Tibia)trauma intramedullary rod, 11.5
- mm diameter
CDT11.5-30T240CDT11.5-30T255CDT11.5-30T270CDT11.5-30T285CDT11.5-30T300CDT11.5-30T315CDT11.5-30T330CDT11.5-30T345CDT11.5-30T360CDT11.5-30T375CDT11.5C-30T240CDT11.5C-30T255CDT11.5C-30T270CDT11.5C-30T285CDT11.5C-30T300CDT11.5C-30T315CDT11.5C-30T330CDT11.5C-30T345CDT11.5C-30T360CDT11.5C-30T375trauma intramedullary rod12.5
- mm diameter
CDT12.5-30T240CDT12.5-30T255CDT12.5-30T270CDT12.5-30T285CDT12.5-30T300CDT12.5-30T315CDT12.5-30T330CDT12.5-30T345CDT12.5-30T360CDT12.5-30T375CDT12.5C-30T240CDT12.5C-30T255CDT12.5C-30T270CDT12.5C-30T285CDT12.5C-30T300CDT12.5C-30T315CDT12.5C-30T330CDT12.5C-30T345CDT12.5C-30T360CDT12.5C-30T375
- end cap for trauma intramedullary nail
TEC1-000TEC1-005TEC1-010TEC1-015TEC1-020
- Locking screws
91 of 91 codes
TSA4.5-020TSA4.5-025TSA4.5-030TSA4.5-035TSA4.5-040TSA4.5-045TSA4.5-050TSA4.5-055TSA4.5-060TSA4.5-065TSA4.5-070TSA4.5-075TSA4-020TSA4-022.5TSA4-025TSA4-027.5TSA4-030TSA4-032.5TSA4-035TSA4-037.5TSA4-040TSA4-042.5TSA4-045TSA4-047.5TSA4-050TSA4-055TSA4-060TSA4-065TSA4-070TSA4-075TSA4-080TSA4-085TSA4-090TSA4-095TSA4-100TSA4-100TSA5-020TSA5-020TSA5-022.5TSA5-022.5TSA5-025TSA5-025TSA5-027.5TSA5-027.5TSA5-030TSA5-030TSA5-032.5TSA5-032.5TSA5-035TSA5-035TSA5-037.5TSA5-037.5TSA5-040TSA5-040TSA5-042.5TSA5-042.5TSA5-045TSA5-045TSA5-047.5TSA5-047.5
- GTIN Number (for Tibia)
137 of 137 codes
008122580273220081225802733900812258027346008122580273530081225802736000812258027377008122580273840081225802739100812258027407008122580274140081225802742100812258027438008122580274450081225802745200812258027469008122580274760081225802748300812258027490008122580275060081225802751300812258027520008122580275370081225802754400812258027551008122580275680081225802757500812258027582008122580275990081225802760500812258027612008122580276290081225802763600812258027643008122580276500081225802766700812258027674008122580276810081225802769800812258027704008122580277110081225802803900812258028046008122580280530081225802806000812258028077008875179360110088751793602800887517936035008875179360420088751793605900887517936066008875179360730088751793608000887517936097008875179362020088751793621900887517936226008875170000330088751700004000887517000057
- Codes (covers both Humerus and Tibia)trauma intramedullary rod, 10.7
- mm diameter
T10.7-50A205T10.7-50A225T10.7-50A240T10.7-50B205T10.7-50B225T10.7-50B240T10.7-50C205T10.7-50C225T10.7-50C240T10.7-50D205T10.7-50D225T10.7-50D240T10.7-50E205T10.7-50E225T10.7-50E240T10.7-80A255T10.7-80A285T10.7-80A315T10.7-80A345T10.7-80A375T10.7-80B255T10.7-80B285T10.7-80B315T10.7-80B345T10.7-80B375T10.7-80C255T10.7-80C285T10.7-80C315T10.7-80C345T10.7-80C375T10.7-80D255T10.7-80D285T10.7-80D315T10.7-80D345T10.7-80D375T10.7-80E255T10.7-80E285T10.7-80E315T10.7-80E345T10.7-80E375trauma intramedullary rod12.5
- mm diameter
T12.5-50A205T12.5-50A225T12.5-50A240T12.5-50B205T12.5-50B225T12.5-50B240T12.5-50C205T12.5-50C225T12.5-50C240T12.5-50D205T12.5-50D225T12.5-50D240T12.5-50E205T12.5-50E225T12.5-50E240T12.5-80A255T12.5-80A285T12.5-80A315T12.5-80A345T12.5-80A375T12.5-80B255T12.5-80B285T12.5-80B315T12.5-80B345T12.5-80B375T12.5-80C255T12.5-80C285T12.5-80C315T12.5-80C345T12.5-80C375T12.5-80D255T12.5-80D285T12.5-80D315T12.5-80D345T12.5-80D375T12.5-80E255T12.5-80E285T12.5-80E315T12.5-80E345T12.5-80E375trauma intramedullary rod8.5
- mm diameter
T8.5-50A205T8.5-50A225T8.5-50A240T8.5-50B205T8.5-50B225T8.5-50B240T8.5-50C205T8.5-50C225T8.5-50C240T8.5-50D205T8.5-50D225T8.5-50D240T8.5-50E205T8.5-50E225T8.5-50E240T8.5-80A255T8.5-80A285T8.5-80A315T8.5-80A345T8.5-80A375T8.5-80B255T8.5-80B285T8.5-80B315T8.5-80B345T8.5-80B375T8.5-80C255T8.5-80C285T8.5-80C315T8.5-80C345T8.5-80C375T8.5-80D255T8.5-80D285T8.5-80D315T8.5-80D345T8.5-80D375T8.5-80E255T8.5-80E285T8.5-80E315T8.5-80E345T8.5-80E375GTIN
- Number (covers both Humerus and Tibia)
120 of 120 codes
008122580238360081225802384300812258023850008122580231190081225802312600812258023133008122580235910081225802360700812258023614008122580233550081225802336200812258023379008122580240790081225802408600812258024093008122580238670081225802387400812258023881008122580238980081225802390400812258023140008122580231570081225802316400812258023171008122580231880081225802362100812258023638008122580236450081225802365200812258023669008122580233860081225802339300812258023409008122580234160081225802342300812258024109008122580241160081225802412300812258024130008122580241470081225802391100812258023928008122580239350081225802319500812258023201008122580232180081225802367600812258023683008122580236900081225802343000812258023447008122580234540081225802415400812258024161008122580241780081225802394200812258023959008122580239660081225802397300812258023980
- Amount recalled
- 229 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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