Z-0609-2014Class II

Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the...

Name: Z-0609-2014 Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the...
Creator: Zimmer, Inc.
Published: 2013-12-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-12-10 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or... on 2013-12-10. FDA classified it as Class II and gives the reason as "Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer...". 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-0609-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Posted: 2013-12-30
Terminated: 2014-09-11
Recalling firm: Zimmer GmbH
Product: Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Zimmer sent an Urgent Medical Device Recall letter dated December 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. If affected product was found, it should be quarantines and their Zimmer representative notified. The Zimmer sales representative will remove the recalled product from their facility. Customers with questions were instructed to call 1-877-946-2761. .
Quantity in commerce: 25
Distribution: Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.
Product codes and lots: Part 00-4349-036-11, Lot 62393502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0608-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-30
Z-0609-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-30
Z-0610-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-30

Product code KWT

K130661Class IIZimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. / cleared 2013-05-09

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)