NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengt

FDA device recall Z-1349-2021 · posted 2021-04-05 · Open, Classified

Recall details

Recalling firm

Nuvasive Specialized Orthopedics Inc

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.

Action taken

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 FSNprecice@nuvasive.com -Report to NSO any adverse effect or product complaints related to the use of these devices to FSNprecice@nuvasive.com, 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

Root cause

Device Design

Status

Open, Classified

Product code

HSB

Quantity affected

10,657 units

Distribution

Worldwide distribution, including U.S. Nationwide.

Date initiated

2021-02-12

Date posted

2021-04-05

Location

Aliso Viejo, CA

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