Mako Surgical Recalls RESTORIS PST RIO Offset Shell Impactor
Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.
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 in a surgical instrument used during a major procedure, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor. This medical device is used by orthopedic surgeons for positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
The recall is being conducted because of a potential disassociation of the orientation pin. The affected units are identified by lot numbers 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
The recalled products were distributed nationwide to facilities in Alabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin. Healthcare facilities should contact Mako Surgical Corporation for instructions on how to return the affected devices.
The recalled product
- Product
- RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 96
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 (7)
- Lot #'s 28548
- 29130
- 29479
- 30440
- 31801
- 31802
- and 32145.
Distribution
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