Z-0267-2013Class II

Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different...

Name: Z-0267-2013 Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different...
Creator: Medacta Usa Inc
Published: 2008-10-13
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2008-10-13 / Terminated / root cause: manufacturing process

FDA source

Medacta Usa Inc began a recall of Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in... on 2008-10-13. FDA classified it as Class II and gives the reason as "Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to...". 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-0267-2013
Classification: Class II
Status: Terminated
Initiated: 2008-10-13
Posted: 2012-11-08
Terminated: 2012-11-09
Recalling firm: Medacta USA, Inc.
Product: Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medacta USA, sent a Urgent Safety Notification letter dated October 13, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter informed the customers of the lot numbers on recall and the reference numbers. The recall was initiated because the offset broach handles contain a lever mechanism that is connected to the locking axis by means of a metallic wire. The rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. For further questions please call (858) 705-0350.
Quantity in commerce: 12 units
Distribution: Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Product codes and lots: Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0267-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0267-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code JDI

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)