Z-0061-2013Class II

CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems...

Name: Z-0061-2013 CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems...
Creator: Zimmer, Inc.
Published: 2012-09-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-13 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty on 2012-09-13. FDA classified it as Class II and gives the reason as "Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices...". 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-0061-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-13
Posted: 2012-10-15
Terminated: 2014-01-15
Recalling firm: Zimmer GmbH
Product: CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Reason for recall: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.
Quantity in commerce: 20
Distribution: Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
Product codes and lots: Lot 62017554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0061-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0060-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0061-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0062-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)