FDA Enforcement
Class II
Terminated
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: Z-2160-2017
·
Reported May 31, 2017
Enforcement
- Recall Number
- Z-2160-2017
- Event ID
- 77148
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 31, 2017
- Initiation Date
- April 26, 2017
- Classification Date
- May 24, 2017
- Termination Date
- February 7, 2020
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
Description
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.
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 Info
Lot Numbers: J49236, V07241, V30655, V47575 and V49404
Distribution
US Nationwide distribution in the states of CA, FL, MD and VT
Quantity
437 units