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Terminated

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

FDA Recall Z-0597-2018 · Posted None

Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeOSH
Date Initiated2017-08-03
Date Terminated2019-05-08
Product Quantity24 units

Reason for Recall

The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

Firm Action

On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to [email protected] or calling (574) 268-3692

Root Cause

Employee error

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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