Z-0277-2013Class II

Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide...

Name: Z-0277-2013 Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide...
Creator: Synthes USA HQ, Inc.
Published: 2012-09-28
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-09-28 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require... on 2012-09-28. FDA classified it as Class II and gives the reason as "The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0277-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Posted: 2012-11-13
Terminated: 2015-09-21
Recalling firm: Synthes GmbH
Product: Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated September 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Verification Form via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this notice.
Quantity in commerce: 8
Distribution: Nationwide 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-0277-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0277-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13

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)