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 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm;
Check against the official notice below — it lists the full affected range.
Nuvasive Specialized Orthopedics Inc. has recalled NUVASIVE FREEDOM End Cap components for the PRECICE Intramedullary Limb Lengthening System. The recall affects 59 units distributed worldwide, including throughout the United States. The devices involved were manufactured between April 2015 and February 2021 and include various end cap sizes (8.5/10.7mm in +0mm and +5mm configurations), locking screws, limb lengthening rods, and surgical instruments identified by specific product codes and GTIN numbers.
The recall was issued because the devices lack the complete biological assessments necessary for all potential patients and are therefore not indicated for use in individuals under 18 years old. The source does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Quantity: 59 units Lot/code info: All Lots manufactured between April 2015 to February 2021. NUVASIVE Freedom Product Codes: End Caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020; Locking screws: LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100; Limb lengthening intramedullary rod, residual limb lengthener: R14-100A130; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener: RLL1-000; GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.