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Terminated

Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

FDA Recall Z-1261-2013 · Posted 2013-05-07

Recalling FirmSpinal Elements, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2009-04-17
Date Terminated2013-05-07
Product Quantity68 units total

Reason for Recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Firm Action

Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in OH and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071914MERCURY SPINAL SYSTEMSpinal Elements, Inc. · 2007-10-12

Official Source

View FDA Recall →

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

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