Medacta Recalls GMK Intramedullary Extension Rods Due to Breakage Reports
Medacta is recalling GMK Intramedullary Extension Rods 100 mm after three reported cases of breakage during total knee replacement surgeries.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a medical device used during surgery, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.
Plain-English summary
Medacta USA is recalling the GMK Intramedullary Extension Rod 100 mm (Model Number: 02.07.10.0162). This medical device is a rod used to obtain correct leg alignment during total knee replacement surgeries.
The recall was initiated because Medacta registered three cases of breakage of the rod in its database. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including in the United States (specifically Ohio) and internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland. A total of 145 rods were distributed globally, with 1 rod in the US. Healthcare providers and patients who have used this specific model should contact Medacta for further instructions.
The recalled product
- Product
- GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
- Manufacturer
- Medacta Usa
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 (1)
- Model Number: 02.07.10.0162
Distribution
Distributed in 1 state:
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