Mako Surgical Corporation RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. Recall
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
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Brand
Mako Surgical Corporation
Lot Codes / Batch Numbers
Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.
Products Sold
Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.
Mako Surgical Corporation is recalling RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for us due to MAKO has identified the potential that the shell impactors may be damaged intraoperatively.. 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
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
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 noticePage updated: Jan 10, 2026