—#155039

Product

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.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K153377
Affected lot / code info: Lot Numbers: J49236, V07241, V30655, V47575 and V49404

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker sent via FedEx an "Urgent Medical Device Recall Notification and Business Reply Form" dated April 26, 2017 to their affected customers. For questions call (201) 831-6693.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, FL, MD and VT

Timeline

Recall initiated: 2017-04-26
Terminated: 2020-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.