Z-0202-2015Class II

GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee...

Name: Z-0202-2015 GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee...
Creator: Medacta Usa
Published: 2014-09-22
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2014-09-22 / Terminated / root cause: manufacturing process

FDA source

Medacta Usa began a recall of GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during... on 2014-09-22. FDA classified it as Class II and gives the reason as "Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0202-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-22
Posted: 2014-11-12
Terminated: 2015-05-07
Recalling firm: Medacta USA, Inc.
Product: GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.
Quantity in commerce: 1 rod (US); 145 rods (global)
Distribution: Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
Product codes and lots: Model Number: 02.07.10.0162

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-12

Product code HSB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)