Z-1804-2010

Synthes Medullary Tubes

Name: Z-1804-2010 Synthes Medullary Tubes
Creator: Synthes USA (HQ), Inc.
Published: 2010-04-01
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-04-01 / Terminated / root cause: sterility

FDA source

Synthes USA (HQ), Inc. began a recall of Synthes Medullary Tubes on 2010-04-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1804-2010
Status: Terminated
Initiated: 2010-04-01
Posted: 2010-06-16
Terminated: 2015-03-25
Recalling firm: Synthes GmbH
Product: Synthes Medullary Tubes
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 18,505 tubes
Distribution: The product was shipped to medical facilities nationwide.
Product codes and lots: Catalog number 355.01. all lot numbers

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)