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TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF… recallZ-2069-2013 · Waldemar Link GmbH & Co. KG (Corp. Hq.) · initiated Jul 16, 2013

Class II Terminated All recalls posted in August 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 Waldemar Link GmbH & Co. KG (Corp. Hq.) 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 stems were manufactured using the wrong design.

FDA root cause category: Device Design

What the company is doing

The firm notified their consignees of their product recall by parcel post on 07/16/2013.

Recall details

Recall number
Z-2069-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 16, 2013
Posted by the FDA
Aug 26, 2013
Recalling firm
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Quantity
9 units
Product code
HWT
FDA submissions
K955296
Distribution
US Distribution to the state of Tennessee only.

Product description

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

Code information (models, lots, serial numbers)

Lots: B226103, B051034

Other devices under the same FDA submission

1 device cleared under K955296 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65800).

Sources and updates

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