Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1676-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 11, 2013

Date Posted: July 17, 2013

Recall Number: Z-1676-2013

Event ID: 65290

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.

Status: Terminated

Product Quantity: 1

Code Information:

Item 00-4301-012-17; lot 62283991

Distribution Pattern:

Nationwide Distribution including IL and MO.

Voluntary or Mandated:

Voluntary: Firm initiated