Z-1816-2013Class II

Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599...

Name: Z-1816-2013 Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599...
Creator: Synthes USA HQ, Inc.
Published: 2012-10-12
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-10-12 / Open, Classified / root cause: packaging

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for... on 2012-10-12. FDA classified it as Class II and gives the reason as "It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1816-2013
Classification: Class II
Status: Open, Classified
Initiated: 2012-10-12
Posted: 2013-07-29
Recalling firm: Synthes GmbH
Product: Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
Root cause tag: packaging
FDA root cause: Packaging
Action: Synthes sent a Urgent Notice Medical Device Recall letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is requesting that you please examine your inventory for products with the above Part and Lot number and remove them. Call Synthes at 1-800-479-6329. If you have any further questions please call 610-719-5450.
Quantity in commerce: 8
Distribution: US Distribution including the states of CA, MN, NC and TN.
Product codes and lots: Part Number 390.007, Lot Number 6800599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1816-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1816-2013	Class II	Ongoing	Voluntary: Firm initiated	2013-08-07	2013-07-29

Product code KTT

K082650Class IISynthes Large External Fixation, Mr ConditionalSynthes (Usa) / cleared 2008-11-18

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)