Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Recall Z-2078-2013 · Posted 2013-08-26

Recalling FirmWaldemar Link GmbH & Co. KG (Corp. Hq.)
Recall StatusTerminated
Product CodeHWT
Date Initiated2013-07-16
Date Terminated2014-06-04
Product Quantity8 units

Reason for Recall

The trial stems were manufactured using the wrong design.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

US Distribution to the state of Tennessee only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955296LINK MP RECONSTRUCTION HIPLink America, Inc. · 1996-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑