Z-0423-2015Class II

Trabecular Metal Tibial Impactor

Name: Z-0423-2015 Trabecular Metal Tibial Impactor
Creator: Zimmer, Inc.
Published: 2014-10-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-10-14 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the... on 2014-10-14. FDA classified it as Class II and gives the reason as "To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture". 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-0423-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-14
Posted: 2014-11-24
Terminated: 2015-06-09
Recalling firm: Zimmer GmbH
Product: Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Product code: HWA Impactor
Reason for recall: To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 10/14/2014, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-877-946-2761.
Quantity in commerce: 1165 units
Distribution: Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.
Product codes and lots: Item 00-5953-056-00; all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0423-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0423-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-23
Z-0424-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-23

Product code HWA

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