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Nuvasive Freedom recallZ-1351-2021 · Nuvasive Specialized Orthopedics Inc · initiated Feb 12, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nuvasive Specialized Orthopedics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

On 02/11/2021, the firm started emailing an "URGENT FIELD SAFETY NOTICE" Notification to customers informing them that due to not having the full complement of biological assessments, the devices are not indicated for use in individuals under the age of 18 years old. Customers are informed to: -An Recalling Firm representative will be contacting your office or you to help with any questions or concerns. -Review, complete, sign and return the attached Consignee Confirmation Form accompanying this notification in accordance with the directions on the form. -If a patient has been previously implanted with a listed device and was under the age of 18, consultation may be warranted, at the discretion of the provider. -If a patient has been previously implanted with a listed device and is pregnant, becomes pregnant, or intends to become pregnant, consultation may be warranted, at the discretion of the provider. -Forward this notice to anyone in your facility that needs to be informed. -Direct any additional manufacturer inquiries to [email protected] -Report to NSO any adverse effect or product complaints related to the use of these devices to [email protected], whether or not those adverse effects are related to this FSN. As a reminder, the following guidelines according to the Instructions for Use, including, but not limited to: -The IFU should be consulted on an ongoing basis before and throughout patient treatment with Precice products. -These Precice family of devices are contraindicated in patients in which the Precice devices would cross joint spaces or open epiphyseal growth plates. -These Precice family of devices are contraindicated in patients unwilling or incapable of following postoperative care instructions. -Precice System devices should be removed after an implantation period of no more than one year. -Once the physician determines that the Precice/Short/Freedom/Unyte System has achieved its intended use and is no longer requir

Recall details

Recall number
Z-1351-2021
Status
Open, Classified
Initiated by the company
Feb 12, 2021
Posted by the FDA
Apr 5, 2021
Recalling firm
Nuvasive Specialized Orthopedics Inc
Quantity
59 units
Product code
HSB
FDA submissions
K141739
Distribution
Worldwide distribution, including U.S. Nationwide.

Product description

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; 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;

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 00887517000989; 00887517000996; 00887517001009; 00887517001016; 00887517001023; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; 00812258024239; 00812258026479;

Devices named in this recall

68 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 87353).

Sources and updates

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