The Recall Desk
HighFDA (Devices)·Z-0829-2015·Announced 2014-12-24

Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors

Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.

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 is classified as FDA Class II and 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 Straight Shell Impactors. These are reusable instruments designed for use by orthopedic surgeons to position and implant acetabular cup components during Total Hip Arthroplasty (THA) surgery. The recall involves Part Number 207390 and specific lot numbers: 21948201, 21948302, 21948403, 21948501, 21948605, and 21948704.

The recall was initiated because Mako has identified the potential that the shell impactors may be damaged intraoperatively. The affected units were 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.

This recall is classified as Class II by the FDA. Healthcare providers and facilities should stop using the affected instruments and contact Mako Surgical Corporation for instructions on return or replacement.

The recalled product

Product
RESTORIS PST Acetabular Straight 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: 207390
  • Lot Numbers: 21948201
  • 21948302
  • 21948403
  • 21948501
  • 21948605 and 21948704.

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 →

Related recalls

Same manufacturer · Mako Surgical Corporation

See all →