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Synthes External Fixation System Tube to Tube Clamp, Part… recallZ-0277-2013 · Synthes USA HQ, Inc. · initiated Sep 28, 2012

Class II Terminated All recalls posted in November 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0277-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 28, 2012
Posted by the FDA
Nov 13, 2012
Recalling firm
Synthes USA HQ, Inc.
Quantity
8
Product code
KTT
FDA submissions
K082650
Distribution
Nationwide Distribution-including the states of CA, MN, NC, and TN.

Product description

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.

Code information (models, lots, serial numbers)

Part number 390.007, Lot number 6800599

Other devices under the same FDA submission

32 devices cleared under K082650 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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