Recall Z-0582-2015— Skeletal Dynamics

Name: FDA recall Z-0582-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-16

Class II · Terminated

Class II FDA medical device recall by Skeletal Dynamics, initiated 2014-10-16, terminated 2016-12-14. It names one FDA 510(k) clearance: K092721. 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 resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.. Reason: Report received where the Align Radial Stem fractured..

Recalling firm: Skeletal Dynamics
Classification: Class II
Status: Terminated
Initiated: 2014-10-16
Terminated: 2016-12-14
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K092721 — ALIGN RADIAL HEAD SYSTEMSkeletal Dynamics, LLC·cleared 2010-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.

Reason for recall

Report received where the Align Radial Stem fractured.

Data sourced from openFDA. This site is unofficial and independent of the FDA.