FDA Medical Device Recalls (openFDA)
Medacta Usa Inc: 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.
- Recall number
- Z-0791-2013
- 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.
- Status
- Terminated
- Initiated
- 2012-12-17
- Posted
- 2013-02-07
- Terminated
- 2013-02-07
- Reason
- The tip of the Quadra Trial Broach size 0, broke during a surgery.
- 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 QA@medacta.us.com 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
- 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
- Lot, serial or model codes
- Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
- 510(k) numbers
- ["K072857","K082792","K083558","K093944","K103189"]
- PMA numbers
- not on file
- Product code
- MEH
- 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