Z-0791-2013Class II

Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System...

Name: Z-0791-2013 Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System...
Creator: Medacta Usa Inc
Published: 2012-12-17
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2012-12-17 / Terminated / root cause: design

FDA source

Medacta Usa Inc began a recall of Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary... on 2012-12-17. FDA classified it as Class II and gives the reason as "The tip of the Quadra Trial Broach size 0, broke during a surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0791-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-17
Posted: 2013-02-07
Terminated: 2013-02-07
Recalling firm: Medacta USA, Inc.
Product: Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: The tip of the Quadra Trial Broach size 0, broke during a surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact [email protected] for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.
Quantity in commerce: 26 pieces U.S.A. (226 pieces Worldwide)
Distribution: US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Product codes and lots: Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0791-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0791-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-06

Product code MEH

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)