The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0582-2015·Announced 2014-12-17

Skeletal Dynamics Recalls Align Radial Stems Due to Fracture Reports

Skeletal Dynamics is recalling 1,700 Align Radial Stems because a report was received indicating the device fractured.

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 involves a structural failure (fracture) of a medical device, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations.

Plain-English summary

Skeletal Dynamics is recalling 1,700 units of the Align Radial Stems, a prosthesis used for elbow hemi replacement of the radial head. The recall was initiated after a report was received where the Align Radial Stem fractured.

The affected devices are distributed nationwide, including in Georgia, New Jersey, New Mexico, Illinois, California, Oklahoma, Colorado, New York, Louisiana, Ohio, Florida, Virginia, Maryland, Mississippi, Texas, Iowa, Alabama, Washington, Tennessee, Maine, Connecticut, Wisconsin, Arizona, Nebraska, South Carolina, North Carolina, and Puerto Rico. The recall covers specific catalog and lot numbers listed in the agency's documentation.

Patients who have received this device should contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and…
Manufacturer
Skeletal Dynamics
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,700

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)

  • Cat #s: ALN-RST-0700
  • ALN-RST-0702
  • ALN-RST-0704
  • ALN-RST-0706
  • ALN-RST-0708
  • ALN-RST-0800
  • ALN-RST-0802
  • ALN-RST-0804
  • ALN-RST-0806
  • ALN-RST-0808
  • ALN-RST-0900
  • ALN-RST-0902
  • ALN-RST-0904
  • ALN-RST-0906
  • ALN-RST-0908
  • ALN-RST-1000
  • ALN-RST-1002
  • ALN-RST-1004
  • ALN-RST-1006
  • ALN-RST-1008

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

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