PlainRecalls
FDA Devices Moderate Class II Terminated

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

Reported: September 4, 2013 Initiated: July 16, 2013 #Z-2073-2013

Product Description

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

Reason for Recall

The trial stems were manufactured using the wrong design.

Details

Units Affected
5 units
Distribution
US Distribution to the state of Tennessee only.
Location
Hamburg

Frequently Asked Questions

What product was recalled?
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg. Recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.). Units affected: 5 units.
Why was this product recalled?
The trial stems were manufactured using the wrong design.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2073-2013.