Stryker Restoris RIO Reamer Handle Recalled for Engagement Failure
Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical instrument failure that poses a significant risk of injury during a medical procedure, meeting the criteria for a Severe rating.
Plain-English summary
Mako Surgical Corporation is recalling 595 units of the Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only. The product is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
The recall was initiated because the Offset Cup Reamer Handle may fail to engage its mating components. This failure could occur during the surgical procedure.
The recalled units were distributed worldwide, including in the United States and various international locations. The recall includes all lots of Catalog No. 207080. Healthcare providers should stop using the affected handles and contact Mako Surgical Corporation for further instructions.
The recalled product
- Product
- Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 595
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 (2)
- All lots recalled
- Catalog No. 207080.
Distribution
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