FDAFDA · Food and drugs·Recall number Z-2067-2013
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Published September 4, 2013 · Recall initiated: July 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The trial stems were manufactured using the wrong design.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Distributor
- US Distribution to the state of Tennessee only.
- Lot
- Lots: B048087, B225117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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