Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk
Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a mechanical failure during surgery that could prevent the device from functioning as intended, posing a risk of harm without reported injuries.
Plain-English summary
Medacta USA Inc has initiated a recall of the Quadra S Offset Broach Handle. This medical device is intended to attach to broaches of different sizes to prepare the femoral bone for the implantation of a femoral stem. The recall involves 12 units distributed worldwide, including in the United States (Texas, Nevada, and Colorado) and Belgium.
The recall was initiated because the rivet that locks the metallic wire to the lever may become loose during surgery. If this occurs, it may make it impossible to lock or unlock the broaches. The affected units are identified by the following reference numbers and lot numbers: Ref 01.10.10.122 (Lot # 085119), Ref 01.10.10.123 (Lot # 085120), Ref 01.10.10.124 (Lot # 085244), and Ref 01.10.10.125 (Lot # 085243).
Healthcare providers and facilities should check their inventory for these specific reference and lot numbers. If the affected devices are found, they should be removed from use and returned to Medacta USA Inc according to the instructions provided by the manufacturer.
The recalled product
- 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.
- Manufacturer
- Medacta Usa Inc
- Affected units
- 12
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 (4)
- 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)
Distribution
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