Reported Apr 14, 2021 · Ongoing
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿…
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 FREEDOMEnd 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; 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, residual limb lengthener, 14 mm diameter, 130 mm length; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener
- Lot codes and dates
- All Lots manufactured between April 2015 to February 2021
- NUVASIVE Freedom Product CodesEnd
- Caps
CPA1-000CPA2-000CPA2-005CPA2-010CPA2-015CPA2-020CPA3-000CPA3-005CPA3-010CPA3-015CPA3-020
- Locking screws
LSB4-020LSB4-025LSB4-030LSB4-035LSB4-040LSB4-045LSB4-050LSB4-055LSB4-060LSB5-020LSB5-025LSB5-030LSB5-035LSB5-040LSB5-045LSB5-050LSB5-055LSB5-060LSB5-065LSB5-070LSB5-075LSC4-020LSC4-025LSC4-030LSC4-035LSC4-040LSC4-045LSC4-050LSC4-055LSC4-060LSC4-065LSC4-070LSC4-075LSC4-080LSC4-085LSC4-090LSC4-095LSC4-100LSC5-020LSC5-025LSC5-030LSC5-035LSC5-040LSC5-045LSC5-050LSC5-055LSC5-060LSC5-065LSC5-070LSC5-075LSC5-080LSC5-085LSC5-090LSC5-095LSC5-100Limb lengthening intramedullary rod
- residual limb lengthenerR14-100A130; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod
- residual limb lengthenerRLL1-000
- GTIN Numbers
68 of 68 codes
008122580200020088751700113900887517001146008875170011530088751700116000887517001177008875170011840088751700119100887517001207008875170012140088751700122100856719002763008567190027700085671900278700856719002794008567190028000085671900281700856719002824008567190028310085671900284800856719002886008567190028930085671900290900856719002916008567190029230085671900293000856719002947008567190029540085671900296100856719002978008567190029850085671900299200812258021429008122580214360081225802144300812258021450008122580214670081225802147400812258021481008122580214980081225802150400887517000958008875170009650088751700097200887517000989008875170009960088751700100900887517001016008875170010230081225802151100812258021528008122580215350081225802154200812258021559008122580215660081225802157300812258021580008122580215970081225802160300812258021610
- Amount recalled
- 59 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.
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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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