Reported Apr 14, 2021 · Ongoing
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb…
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 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; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 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; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 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; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 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; Orthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening
- Lot codes and dates
- All Lots manufactured between April 2015 to February 2021. PRECICE Intramedullary
- Limb Lengthening (IMLL) Product CodesEnd
- caps
CPA1-000CPA2-000CPA2-005CPA2-010CPA2-015CPA2-020CPA3-000CPA3-005CPA3-010CPA3-015CPA3-020
- Locking screws
68 of 68 codes
LSB3-020LSB3-025LSB3-030LSB3-035LSB3-040LSB3-045LSB3-050LSB3-055LSB3-060LSB3-065LSB3-070LSB3-075LSB4-020LSB4-025LSB4-030LSB4-035LSB4-040LSB4-045LSB4-050LSB4-055LSB4-060LSB5-020LSB5-025LSB5-030LSB5-035LSB5-040LSB5-045LSB5-050LSB5-055LSB5-060LSB5-065LSB5-070LSB5-075LSC4-020LSC4-025LSC4-030LSC4-035LSC4-040LSC4-045LSC4-050LSC4-055LSC4-060LSC4-065LSC4-070LSC4-075LSC4-080LSC4-085LSC4-090LSC4-095LSC4-100LSC5-020LSC5-025LSC5-030LSC5-035LSC5-040LSC5-045LSC5-050LSC5-055LSC5-060LSC5-065
- mm diameter
63 of 63 codes
P10.7-30H170P10.7-30J160P10.7-30K170P10.7-30U170P10.7-50A215P10.7-50A230P10.7-50B215P10.7-50B230P10.7-50C195P10.7-50C215P10.7-50C230P10.7-50D215P10.7-50D230P10.7-50E215P10.7-50E230P10.7-50H190P10.7-50J180P10.7-50K190P10.7-50M175P10.7-50N160P10.7-50P175P10.7-50Q155P10.7-50U190P10.7-50V215P10.7-50V230P10.7-50X215P10.7-50X230P10.7-80A245P10.7-80A275P10.7-80A305P10.7-80A335P10.7-80A365P10.7-80B245P10.7-80B275P10.7-80B305P10.7-80B335P10.7-80B365P10.7-80C245P10.7-80C275P10.7-80C305P10.7-80C335P10.7-80C365P10.7-80D245P10.7-80D275P10.7-80D305P10.7-80D335P10.7-80D365P10.7-80E245P10.7-80E275P10.7-80E305P10.7-80E335P10.7-80E365P10.7-80V245P10.7-80V275P10.7-80V305P10.7-80V335P10.7-80V365P10.7-80X245P10.7-80X275P10.7-80X305
- mm diameter
P12.5-30H170P12.5-30J160P12.5-30K170P12.5-30U170P12.5-50A215P12.5-50A230P12.5-50B215P12.5-50B230P12.5-50C195P12.5-50C215P12.5-50C230P12.5-50D215P12.5-50D230P12.5-50E215P12.5-50E230P12.5-50H190P12.5-50J180P12.5-50K190P12.5-50U190P12.5-50V215P12.5-50V230P12.5-50X215P12.5-50X230P12.5-80A245P12.5-80A275P12.5-80A305P12.5-80A335P12.5-80A365P12.5-80B245P12.5-80B275P12.5-80B305P12.5-80B335P12.5-80B365P12.5-80C245P12.5-80C275P12.5-80C305P12.5-80C335P12.5-80C365P12.5-80D245P12.5-80D275P12.5-80D305P12.5-80D335P12.5-80D365P12.5-80E245P12.5-80E275P12.5-80E305P12.5-80E335P12.5-80E365P12.5-80V245P12.5-80V275P12.5-80V305P12.5-80V335P12.5-80V365P12.5-80X245P12.5-80X275P12.5-80X305P12.5-80X335P12.5-80X365Limb lengthening intramedullary rods 8.5
- mm diameter
62 of 62 codes
P8.5-30H170P8.5-30J160P8.5-30K170P8.5-30U170P8.5-50A215P8.5-50A230P8.5-50B215P8.5-50B230P8.5-50C195P8.5-50C215P8.5-50C230P8.5-50D215P8.5-50D230P8.5-50E215P8.5-50E230P8.5-50H190P8.5-50J180P8.5-50K190P8.5-50M165P8.5-50N150 P8.5-50P165P8.5-50Q155P8.5-50U190P8.5-50V215P8.5-50V230P8.5-50X215P8.5-50X230P8.5-80A245P8.5-80A275P8.5-80A305P8.5-80A335P8.5-80A365P8.5-80B245P8.5-80B275P8.5-80B305P8.5-80B335P8.5-80B365P8.5-80C245P8.5-80C275P8.5-80C305P8.5-80C335P8.5-80C365P8.5-80D245P8.5-80D275P8.5-80D305P8.5-80D335P8.5-80D365P8.5-80E245P8.5-80E275P8.5-80E305P8.5-80E335P8.5-80E365P8.5-80V245P8.5-80V275P8.5-80V305P8.5-80V335P8.5-80V365P8.5-80X245P8.5-80X275P8.5-80X305P8.5-80X335
- mm diameter
PR10.5-50A215PR10.5-50A230PR10.5-50B215PR10.5-50B230PR10.5-50C195PR10.5-50C215PR10.5-50C230PR10.5-50D215PR10.5-50D230PR10.5-50E215PR10.5-50E230PR10.5-80A245PR10.5-80A275PR10.5-80A305PR10.5-80A335PR10.5-80A365PR10.5-80B245PR10.5-80B275PR10.5-80B305PR10.5-80B335PR10.5-80B365PR10.5-80C245PR10.5-80C275PR10.5-80C305PR10.5-80C335PR10.5-80C365PR10.5-80D245PR10.5-80D275PR10.5-80D305PR10.5-80D335PR10.5-80D365PR10.5-80E245PR10.5-80E275PR10.5-80E305PR10.5-80E335PR10.5-80E365Limb lengthening intramedullary rods 11.5
- mm diameter
PR11.5-50A215PR11.5-50A230PR11.5-50B215PR11.5-50B230PR11.5-50C195PR11.5-50C215PR11.5-50C230PR11.5-50D215PR11.5-50D230PR11.5-50E215PR11.5-50E230PR11.5-80A245PR11.5-80A275PR11.5-80A305PR11.5-80A335PR11.5-80A365PR11.5-80B245PR11.5-80B275PR11.5-80B305PR11.5-80B335PR11.5-80B365PR11.5-80C245PR11.5-80C275PR11.5-80C305PR11.5-80C335PR11.5-80C365PR11.5-80D245PR11.5-80D275PR11.5-80D305PR11.5-80D335PR11.5-80D365PR11.5-80E245PR11.5-80E275PR11.5-80E305PR11.5-80E335PR11.5-80E365Limb lengthening intramedullary rods 12.5
- mm diameter
PR12.5-50A215PR12.5-50A230PR12.5-50B215PR12.5-50B230PR12.5-50C195PR12.5-50C215PR12.5-50C230PR12.5-50D215PR12.5-50D230PR12.5-50E215PR12.5-50E230PR12.5-80A245PR12.5-80A275PR12.5-80A305PR12.5-80A335PR12.5-80A365PR12.5-80B245PR12.5-80B275PR12.5-80B305PR12.5-80B335PR12.5-80B365PR12.5-80C245PR12.5-80C275PR12.5-80C305PR12.5-80C335PR12.5-80C365PR12.5-80D245PR12.5-80D275PR12.5-80D305PR12.5-80D335PR12.5-80D365PR12.5-80E245PR12.5-80E275PR12.5-80E305PR12.5-80E335PR12.5-80E365Limb lengthening intramedullary rods 9.0
- mm diameter
PR9.0-50A215PR9.0-50A230PR9.0-50B215PR9.0-50B230PR9.0-50C195PR9.0-50C215PR9.0-50C230PR9.0-50D215PR9.0-50D230PR9.0-50E215PR9.0-50E230PR9.0-80A245PR9.0-80A275PR9.0-80A305PR9.0-80A335PR9.0-80A365PR9.0-80B245PR9.0-80B275PR9.0-80B305PR9.0-80B335PR9.0-80B365PR9.0-80C245PR9.0-80C275PR9.0-80C305PR9.0-80C335PR9.0-80C365PR9.0-80D245PR9.0-80D275PR9.0-80D305PR9.0-80D335PR9.0-80D365PR9.0-80E245PR9.0-80E275PR9.0-80E305PR9.0-80E335PR9.0-80E365Limb lengthening intramedullary rods 9.5
- mm diameter
PR9.5-50A215PR9.5-50A230PR9.5-50B215PR9.5-50B230PR9.5-50C195PR9.5-50C215PR9.5-50C230PR9.5-50D215PR9.5-50D230PR9.5-50E215PR9.5-50E230PR9.5-80A245PR9.5-80A275PR9.5-80A305PR9.5-80A335PR9.5-80A365PR9.5-80B245PR9.5-80B275PR9.5-80B305PR9.5-80B335PR9.5-80B365PR9.5-80C245PR9.5-80C275PR9.5-80C305PR9.5-80C335PR9.5-80C365PR9.5-80D245PR9.5-80D275PR9.5-80D305PR9.5-80D335PR9.5-80D365PR9.5-80E245PR9.5-80E275PR9.5-80E305PR9.5-80E335PR9.5-80E365Trauma intramedullary rods 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 rods 12.5
- 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 rods 8.5
- mm diameter
T8.5-50A205T8.5-50A225T8.5-50A240T8.5-50B205T8.5-50B225T8.5-50B240T8.5-50C205T8.5-50C225T8.5-50C240T8.5-50D205T8.5-50D225T8.5-50D240T8.5-50E205T8.5-50E225T8.5-50E240T8.5-80A255T8.5-80A285T8.5-80A315T8.5-80A345T8.5-80A375T8.5-80B255T8.5-80B285T8.5-80B315T8.5-80B345T8.5-80B375T8.5-80C255T8.5-80C285T8.5-80C315T8.5-80C345T8.5-80C375T8.5-80D255T8.5-80D285T8.5-80D315T8.5-80D345T8.5-80D375T8.5-80E255T8.5-80E285T8.5-80E315T8.5-80E345T8.5-80E375
- 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 Numbers
651 of 651 codes
008122580200020088751700113900887517001146008875170011530088751700116000887517001177008875170011840088751700119100887517001207008875170012140088751700122100812258021337008122580213440081225802135100812258021368008122580213750081225802138200812258021399008122580214050081225802141200887517936233008875179362400088751793625700856719002763008567190027700085671900278700856719002794008567190028000085671900281700856719002824008567190028310085671900284800856719002886008567190028930085671900290900856719002916008567190029230085671900293000856719002947008567190029540085671900296100856719002978008567190029850085671900299200812258021429008122580214360081225802144300812258021450008122580214670081225802147400812258021481008122580214980081225802150400887517000958008875170009650088751700097200887517000989008875170009960088751700100900887517001016
- Amount recalled
- 10,657 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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