PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-u

FDA device recall Z-1323-2021 · posted 2021-03-30 · Open, Classified

Recall details

Recalling firm

Nuvasive Specialized Orthopedics Inc

Reason for recall

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

Action taken

On 02/12/2021, the firm sent via email an "URGENT FIELD SAFETY NOTICE" that informed customers that There have been several reports of adverse events potentially related to biological safety in one of the device systems, which are currently under investigation. The events include reports of pain and bony abnormalities at the interface between the telescoping nail segments. The Recalling Firm is informing its customers that the affected devices are not indicated for use in individuals younger than 18 years of age and instructing/informing them: -That an Recalling Firm representative will be contacted their office or they will be provided instructions for returning the affected product. -To not implant the affected devices until further notice. -To review, complete, sign and return the Consignee Confirmation Form by scanning and emailing the form to FSNprecice@nuvasive.com. -The affected devices will not be available until further notice. -Prophylactic removal of functioning devices is not recommended. Instead, any treatment decisions should be made by the physician in consultation with the patient and/or family. -For any patients, assessment of any symptoms, via consultation, and radiography should be made to determine if pain and abnormal bony changes might be present, as described above. --- If so, then clinical care decisions should be made at the discretion of the healthcare team, in consultation with the patient and any other relevant decision makers. -If a patient has been previously implanted with the 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.co

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HSB

Quantity affected

2360 units

Distribution

Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, I

Date initiated

2021-02-12

Date posted

2021-03-30

Location

Aliso Viejo, CA

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