Mako Surgical Recalls Mislabelled Restoris MCK Tibial Baseplates
Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is incorrect labeling with no reported illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Mako Surgical Corporation is recalling 126 units of the Restoris MCK Tibial Baseplate-RM/LL. These medical devices are used in unicompartmental knee arthroplasty and knee replacements. The recall was initiated because the product and/or label sizing is incorrect.
The affected units include Size 2 (Item # 180612, Lot # 26080317-01) and Size 7 (Item # 180617, Lot # 26150217-01). The devices were distributed to facilities in 32 US states and Hawaii, as well as Australia, Italy, the Netherlands, Singapore, South Korea, the United Kingdom, and Vietnam.
The FDA has classified this as a Class II recall. The source text does not report any illnesses or injuries associated with this labeling error. Healthcare providers and patients should contact Mako Surgical Corporation for further instructions regarding the affected lots.
The recalled product
- Product
- RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 126
Distribution
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