Medacta Quadra Trial Broach size 0 recalled due to tip breakage
Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that broke during surgery, representing a risk-of-harm product where injury has not yet been explicitly reported in the source text, fitting the High severity criteria.
Plain-English summary
Medacta USA Inc. is recalling 26 units of the Medacta Quadra Trial Broach size 0, part number 01.10.10.045. This medical device is used in hip replacement surgery to broach the intramedullary canal of the femur to create space for the femoral stem. The recall involves 26 pieces distributed in the United States, with an additional 226 pieces distributed worldwide.
The recall was initiated because the tip of the Quadra Trial Broach size 0 broke during a surgery. The affected units are identified by the following lot codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, and 085455.
The product was distributed nationwide in the United States, including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington, and the US Virgin Islands. Healthcare providers and facilities should stop using the affected devices and contact Medacta USA Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Medacta Usa Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot/Unit Codes: 075023
- 075064
- 084000
- 084001
- 084326
- 084743
- 084815
- 085202
- 085455
Distribution
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