FDA-Device2017-05-31Class II
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
Sold states
US Nationwide distribution in the states of CA, FL, MD and VT
Affected count
437 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2017Don't want to check this manually?
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