GMK Intramedullary Extension Rod (Medacta) – Rod Breakage Risk (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medacta Usa
Lot Codes / Batch Numbers
Model Number: 02.07.10.0162
Products Sold
Model Number: 02.07.10.0162
Medacta Usa is recalling GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee r due to Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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Page updated: Jan 10, 2026