RecallDepth

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.

Company
Stryker Howmedica Osteonics Corp.
Recall Initiated
April 26, 2017
Terminated
February 7, 2020
Recall Number
Z-2160-2017
Quantity
437 units
Firm Location
Mahwah, NJ

Reason for Recall

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.

Distribution

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

Lot / Code Info

Lot Numbers: J49236, V07241, V30655, V47575 and V49404

Root Cause

Device Design

Action Taken

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.

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