Skip to content

Synthes Large External Fixation, MR Conditional, Tube to… recallZ-1816-2013 · Synthes USA HQ, Inc. · initiated Oct 12, 2012

Class II Open, Classified All recalls posted in July 2013

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

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.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-1816-2013
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 12, 2012
Posted by the FDA
Jul 29, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
8
Product code
KTT
FDA submissions
K082650
Distribution
US Distribution including the states of CA, MN, NC and TN.

Product description

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.

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

How recalls are matched to devices · Editorial policy · Report an error on this page