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Terminated

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

FDA Recall Z-0644-2018 · Posted None

Recalling FirmInnovasis, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2018-01-08
Date Terminated2018-02-27
Product Quantity1,010 parts

Reason for Recall

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Firm Action

The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email.

Root Cause

Nonconforming Material/Component

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00Innovasis, Inc. · 2010-10-07

Official Source

View FDA Recall →

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

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