Skip to content

Synthes 4.5 mm LCP Curved Condylar Plate recallZ-0409-2014 · Synthes USA HQ, Inc. · initiated Jul 30, 2013

Class II Terminated All recalls posted in November 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

The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

FDA root cause category: Process control

What the company is doing

Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0409-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Nov 27, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
13
Product code
KTT
FDA submissions
K041911
Distribution
Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.

Product description

Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

Code information (models, lots, serial numbers)

Part No. 02.001.324, lot no. 6900823

Other devices under the same FDA submission

21 devices cleared under K041911 — 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