The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0830-2015·Announced 2014-12-24

Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors

Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged 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 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 risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Mako Surgical Corporation is recalling 404 units of RESTORIS PST Acetabular Offset Shell Impactors. These are reusable instruments used by 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 products 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 units have Part Number 206276 and Lot Numbers 6011112, 6020114, 6030314, 6030712, 6110612, and E453704. Healthcare facilities and users should stop using these specific instruments and contact Mako Surgical Corporation for instructions on how to return or dispose of the recalled items.

The recalled product

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.
Manufacturer
Mako Surgical Corporation
Category
Medical Device — Surgical Instrument
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: 206276
  • Lot Numbers: 6011112
  • 6020114
  • 6030314
  • 6030712
  • 6110612 and E453704.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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 →

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