Z-1676-2013Class II

Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial...

Name: Z-1676-2013 Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial...
Creator: Zimmer, Inc.
Published: 2013-06-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-06-11 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and... on 2013-06-11. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1676-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-07-10
Terminated: 2014-01-30
Recalling firm: Zimmer GmbH
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.
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at [email protected]. For questions regarding this recall call 800-613-6131.
Quantity in commerce: 1
Distribution: Nationwide Distribution including IL and MO.
Product codes and lots: Item 00-4301-012-17; lot 62283991

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

Product code HSD

K110791Class IIBigliani / Flatow (R) the Complete Shoulder SolutionZimmer, Inc. / cleared 2011-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)