Mako Surgical Recalls Restoris MCK Onlay Insert Extractor Due to Hinge Pin Risk
Mako Surgical Corporation is recalling 575 units of the Restoris MCK Onlay Insert Extractor because the hinge pin may disassociate.
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 (hinge pin disassociation) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Mako Surgical Corporation is recalling 575 units of the Restoris MCK Onlay Insert Extractor. The recall was initiated because the hinge pin may disassociate from the device.
The affected units are Item No. 160430 and include specific lot numbers listed in the agency's recall record. The devices were distributed domestically to 29 U.S. states and internationally to nine countries, including Australia, China, Italy, the Netherlands, Singapore, South Africa, Taiwan, Turkey, and the United Kingdom.
Healthcare providers and patients should stop using the affected devices and contact Mako Surgical Corporation for further instructions. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Restoris MCK Onlay Insert Extractor.
- Manufacturer
- Mako Surgical Corporation
- 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 (20)
- Item No. 160430
- Lot No. 19020414
- 19090616
- 19090915
- 19100616
- 19100915
- 19110317
- 19110616
- 19110915
- 19130315
- 19140315
- 19451016
- 19461016
- 19471016
- 19490515
- 19500515
- 19510515
- 19520515
- 19530515
- 26051212
Distribution
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