Reported Dec 17, 2014 · Terminated
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic…
Skeletal Dynamics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skeletal Dynamics · 8905 Sw 87th Ave Ste 201 · Miami, FL · 33176-2227
Is this the product you have?
- 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 withJoint 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
- Lot codes and dates
109 of 109 codes
Cat #s: ALN-RST-0700ALN-RST-0702ALN-RST-0704ALN-RST-0706ALN-RST-0708ALN-RST-0800ALN-RST-0802ALN-RST-0802ALN-RST-0804ALN-RST-0806ALN-RST-0808ALN-RST-0900ALN-RST-0902ALN-RST-0904ALN-RST-0906ALN-RST-0908ALN-RST-1000ALN-RST-1002ALN-RST-1004ALN-RST-1006ALN-RST-1008ALN-RST-1100ALN-RST-1102ALN-RST-1104ALN-RST-1106ALN-RST-1108Lot #s: AN0610023AN0212065AN0913033AN0913034AN0610024AN0913035AN0913036AN0610025AN0913037AN0913038AN0610026AN0913039AN0913040AN0610027AN0913041AN0913042AN0610028AN0212066AN0913043AN0913044AN0610029AN0913045AN0913046AN0610030AN0913047AN0913048AN0610031AN0913049AN0913050AN0610032AN0913051AN0913052AN0610033AN0212067
- Amount recalled
- 1700
Where it was sold
Why it was recalled
Report received where the Align Radial Stem fractured.
This product could cause temporary or reversible health problems — stop using it.
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