Medacta Usa Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medacta Usa Inc
Lot Codes / Batch Numbers
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)
Products Sold
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)
Medacta Usa Inc is recalling Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of dif due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, NV, TX
Page updated: Jan 10, 2026