The Recall Desk
ModerateFDA (Devices)·Z-2197-2017·Announced 2017-06-07

Acumed Recalls Slide-Loc Anatomic Radial Head System Due to Performance Issues

Acumed LLC is voluntarily removing the Slide-Loc Anatomic Radial Head System from the market due to complaints about instrumentation performance, trial design, and implant dissociations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary removal based on performance complaints without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Acumed LLC has initiated a voluntary removal and discontinuation of marketing for the Slide-Loc Anatomic Radial Head System. This medical device is intended for use by surgeons with orthopedic training to replace the proximal portion of the radius. The recall covers 13,076 parts total, including 8,373 units of parts/instruments and 4,703 units of implantable parts, distributed nationwide in 34 states and Puerto Rico.

The firm initiated this action based on the product's performance in the market. Specifically, the company received product complaints regarding instrumentation performance, trial product design, and implant dissociations. The source text does not report any specific injuries, illnesses, or deaths associated with these complaints.

Surgeons and healthcare facilities that have used or possess these devices should contact Acumed LLC for further instructions on the removal and discontinuation of the product. The recall includes specific batch numbers for the sterile implantable parts, which are listed in the official FDA recall notice.

The recalled product

Product
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc S
Manufacturer
Acumed LLC
Category
Medical Device — Orthopedic Implant
Hazard

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 (20)

  • Left 5001-0218R-S ARH Slide-Loc Head 18mm
  • Right 5001-0220L-S ARH Slide-Loc Head 20mm
  • Left 5001-0220R-S ARH Slide-Loc Head 20mm
  • Right 5001-0222L-S ARH Slide-Loc Head 22mm
  • Left 5001-0222R-S ARH Slide-Loc Head 22mm
  • Right 5001-0224L-S ARH Slide-Loc Head 24mm
  • Left 5001-0224R-S ARH Slide-Loc Head 24mm
  • Right 5001-0226L-S ARH Slide-Loc Head 26mm
  • Left 5001-0226R-S ARH Slide-Loc Head 26mm
  • Right 5001-0228L-S ARH Slide-Loc Head 28mm
  • Left 5001-0228R-S ARH Slide-Loc Head 28mm
  • Left 5001-0406R-S ARH Slide-Loc Long Stem 6mm
  • Right 5001-0408L-S ARH Slide-Loc Long Stem 8mm
  • Left 5001-0408R-S ARH Slide-Loc Long Stem 8mm
  • Right 5001-0410L-S ARH Slide-Loc Long Stem 10mm
  • Left 5001-0410R-S ARH Slide-Loc Long Stem 10mm
  • Right 5001-0412L-S ARH Slide-Loc Long Stem 12mm
  • Left 5001-0412R-S ARH Slide-Loc Long Stem 12mm
  • Left 5101-0218R ARH Slide-Loc Trial Head 18mm
  • Right 5101-0220L ARH Slide-Loc Trial Head 20mm

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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