Recall Z-1676-2013— Zimmer, Inc.

Name: FDA recall Z-1676-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-11

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-06-11, terminated 2014-01-30. It names one FDA 510(k) clearance: K110791. Product: Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.. Reason: The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Terminated: 2014-01-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K110791 — BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTIONZimmer, Inc.·cleared 2011-09-02

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

Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.

Reason for recall

The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.

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