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Terminated

Synthes Medullary Tubes

FDA Recall Z-1804-2010 · Posted 2010-06-16

Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-01
Date Terminated2015-03-25
Product Quantity18,505 tubes

Reason for Recall

After repeated sterilizations product may become discolored and break including while in the medullary canal. Synthes has determined that the Medullary Tube will be a single use item that is to be discarded after one sterilization cycle.

Firm Action

The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter. Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide.

Official Source

View FDA Recall →

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

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