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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

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
Recall Number Z-2069-2013
Classification Class II
Code Info Lots: B226103, B051034
Product Distributed Qty 9 units
Reason For Recall The trial stems were manufactured using the wrong design.

Event Detail

Event Id 65800
Product Type Devices
Status Ongoing
Recalling Firm Waldemar Link GmbH & Co. KG (Corp. Hq.)
City Hamburg
Country DE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution to the state of Tennessee only.