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Foundation Tibial Broach P/N 801-01-013 recallZ-0349-2012 · Encore Medical, Lp · initiated Oct 26, 2011

Terminated All recalls posted in December 2011

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 Encore Medical, Lp 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 strike plate may dislodge from the broach stem handle during impaction of the device.

FDA root cause category: Nonconforming Material/Component

What the company is doing

DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.

Recall details

Recall number
Z-0349-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 26, 2011
Posted by the FDA
Dec 2, 2011
Recalling firm
Encore Medical, Lp
Quantity
30 units
Product code
JWH
FDA submissions
K970031
Distribution
Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy

Product description

Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013

Code information (models, lots, serial numbers)

Lot#'s 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12

Other devices under the same FDA submission

11 devices cleared under K970031 — 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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