Skip to content

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part… recallZ-2243-2013 · Synthes USA HQ, Inc. · initiated Apr 18, 2013

Class II Terminated All recalls posted in September 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

Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

FDA root cause category: Packaging process control

What the company is doing

A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.

Recall details

Recall number
Z-2243-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 18, 2013
Posted by the FDA
Sep 18, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
1
Product code
HTY
FDA submissions
K970733
Distribution
US distribution to MA.

Product description

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

Code information (models, lots, serial numbers)

Part Number 450.851S, Lot Number 7065061

Other devices under the same FDA submission

10 devices cleared under K970733 — 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