Synthes Medullary Tubes

FDA device recall Z-1804-2010 · posted 2010-06-16 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

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.

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

18,505 tubes

Distribution

The product was shipped to medical facilities nationwide.

Date initiated

2010-04-01

Date posted

2010-06-16

Date terminated

2015-03-25

Location

West Chester, PA