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Terminated

V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

FDA Recall Z-0069-2017 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2016-09-23
Date Terminated2019-05-10
Product Quantity72,076 units

Reason for Recall

Potential risk associated with corrosion demonstrated on the distraction screw surface.

Firm Action

On September 23, 2016, Becton Dickinson sent a Field Safety Notice to all affected customers describing the details of the recall and necessary action to take. ACTIONS TO BE TAKEN BY BD: A credit will be applied to your account for the affected product upon receipt of the affected unit(s) or receipt of certification of destruction documented on the customer response form. Complete the Recall Response form certifying that all affected product in your inventory has been destroyed and mail/email a copy of the response form.: The firm requests customers to promptly return the enclosed response form to expedite the correction process and acknowledge receipt of this notification. Or email: [email protected] For further questions, please call (847) 473-1500.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.

Official Source

View FDA Recall →

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

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