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.
- 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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