RecallRadar

FDA Device recall Z-0267-2013

Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the…

On 2012-11-14 the FDA classified a Class II 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… by Medacta Usa, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0267-2013
ClassificationClass II
Statusterminated
Initiated2008-10-13
Published2012-11-14
Last updated2026-09-13 11:53 UTC
CompanyMedacta Usa
DistributionCO, NV, TX

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.

Reason

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.

Identifiers

code_infoRef: 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)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0267-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.