Device 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.
Z-2160-2017
Product summary
- Event
- Event 77148
- Status
- Terminated
- Classification
- Class II
- Quantity
- 437 units
- Official record key
device-enforcement:Z-2160-2017
Official wording
Reason: 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.
Code information: Lot Numbers: J49236, V07241, V30655, V47575 and V49404
Distribution pattern: US Nationwide distribution in the states of CA, FL, MD and VT
Derived failure modes
-
Unknown
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.