FDA Medical Device Recalls (openFDA)
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 number
- Z-0267-2013
- 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.
- Status
- Terminated
- Initiated
- 2008-10-13
- Posted
- 2012-11-08
- Terminated
- 2012-11-09
- 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.
- 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
- 12 units
- Distribution
- Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3006639916
- Firm city
- Camarillo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28