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Synthes Radial Head Prosthesis: Trial Radial Head recallZ-1238-2013 · Synthes USA HQ, Inc. · initiated Feb 22, 2013

Class II Terminated All recalls posted in May 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 Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.

FDA root cause category: Device Design

What the company is doing

Synthes sent an Urgent Notice: Medical Device Recall letter dated February 22, 2013, to all affected consignees. The letter requested consignees examine their inventory, remove them from use and return them to Synthes. Customers were asked to complete the attached Verification Section at the end of the letter indicating whether or not they have any of the affected product. For questions customers were instructed to call 610-719-5450 or email [email protected]. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-1238-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 22, 2013
Posted by the FDA
May 3, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
417
Product code
KWI
FDA submissions
K112030
Distribution
Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.

Product description

Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.

Code information (models, lots, serial numbers)

All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.

Other devices under the same FDA submission

21 devices cleared under K112030 — 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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