Recall Z-2063-2013— Waldemar Link GmbH & Co. KG (Corp. Hq.)

Name: FDA recall Z-2063-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-16

Class II · Terminated

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Corp. Hq.), initiated 2013-07-16, terminated 2014-06-04. It names one FDA 510(k) clearance: K955296. Product: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg. Reason: The trial stems were manufactured using the wrong design..

Recalling firm: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Terminated: 2014-06-04
Firm location: Hamburg, Germany

510(k) clearances named in this recall

1 on FDA's record

K955296 — LINK MP RECONSTRUCTION HIPLink America, Inc.·cleared 1996-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

Reason for recall

The trial stems were manufactured using the wrong design.

Data sourced from openFDA. This site is unofficial and independent of the FDA.