Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for… recallZ-0791-2013 · Medacta Usa Inc · initiated Dec 17, 2012
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The tip of the Quadra Trial Broach size 0, broke during a surgery.
FDA root cause category: Device Design
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-0791-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 17, 2012
- Posted by the FDA
- Feb 7, 2013
- Recalling firm
- Medacta Usa Inc
- Quantity
- 26 pieces U.S.A. (226 pieces Worldwide)
- Product code
- MEH
- FDA submissions
- K072857, K082792, K083558, K093944, K103189
- Distribution
- US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Product description
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.
Code information (models, lots, serial numbers)
Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Other devices under the same FDA submission
98 devices cleared under K072857, K082792, K083558, K093944, K103189 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AMIStem H Femoral Stems 01.18.133Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented116 reports
- AMIStem H Femoral Stems 01.18.132Medacta International SA · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 death115 reports
- AMIStem H Femoral Stems 01.18.131Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented74 reports
- AMIStem H Femoral Stems 01.18.134Medacta International SA · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate72 reports
- AMIStem H Femoral Stems 01.18.135Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 death57 reports
- AMIStem H Femoral Stems 01.18.143Medacta International SA · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate42 reports
- Quadra H femoral stems 01.12.023Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented32 reports
- AMIStem H Femoral Stems 01.18.130Medacta International SA · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate32 reports
- AMIStem H Femoral Stems 01.18.144Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented28 reports
- Quadra H femoral stems 01.12.021Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented26 reports
- Quadra H femoral stems 01.12.022Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented26 reports
- Quadra H femoral stems 01.12.024Medacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented25 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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