Mako Surgical Recalls RESTORIS PST Straight Shell Impactors
Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.
What this means for you
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 involves a medical device with a risk of intraoperative damage, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Mako Surgical Corporation is recalling 404 units of the RESTORIS PST Straight Shell Inserter. This reusable instrument is designed for orthopedic surgeons to position and implant acetabular cup components during Total Hip Arthroplasty (THA) surgery.
The recall was initiated because Mako identified the potential that the shell impactors may be damaged intraoperatively. The affected units are distributed nationwide, including in Illinois, Ohio, Arizona, Colorado, Georgia, Oklahoma, North Carolina, Virginia, Connecticut, Florida, California, Massachusetts, New York, Michigan, New Hampshire, Texas, Louisiana, Washington, New Jersey, Rhode Island, Idaho, Tennessee, Indiana, Pennsylvania, and Wisconsin.
The affected products are identified by Part Number 112710 and Lot Numbers 120027, 120041, 120052, 120074, 120076, and 120075. The source text does not specify specific consumer actions or report any injuries or illnesses associated with this recall.
The recalled product
- Product
- RESTORIS PST Straight Shell Inserter 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.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 404
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 (6)
- Part Number: 112710
- Lot Numbers: 120027
- 120041
- 120052
- 120074
- 120076 and 120075.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mako Surgical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Mako Surgical Corporation
See all →- ModerateStryker USB Converter in Mako Robotic Surgery System May Fail
FDA (Devices) · 2022-09-21
- HighMako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
FDA (Devices) · 2020-11-25
- HighMako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
FDA (Devices) · 2020-08-12
- ModerateMako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
- ModerateMako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
Same hazard · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighBaxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
FDA (Devices) · 2022-02-16
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21