Z-1895-2012Class II

Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the...

Name: Z-1895-2012 Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the...
Creator: Zimmer, Inc.
Published: 2012-05-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-05-12 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use... on 2012-05-12. FDA classified it as Class II and gives the reason as "Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1895-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-12
Posted: 2012-06-27
Terminated: 2013-09-12
Recalling firm: Zimmer GmbH
Product: Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Zimmer sent URGENT DEVICE REMOVAL NOTIFICATION emails to distributors on May 12, 2012 to remove the product from all locations in their territories. This was an initial notification to prevent further distribution and use of the product. Zimmer Inc. sent follow-up notifications dated June 7, 2012 to the distributors, surgeons and hospital user accounts describing the product issue and providing recommended actions. Customers were directed to (877) 946-2761 for assistance or questions.
Quantity in commerce: 87 units
Distribution: Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
Product codes and lots: Catalog number 47-4307-031-00; lot 62071190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1895-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1895-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27

Product code KWT

K103404Class IIAna0tomical Shoulder Tm Combined SystemZimmer GmbH / cleared 2011-03-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)