Device product
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
Z-2816-2020
Product summary
- Event
- Event 86104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 191 units
- Official record key
device-enforcement:Z-2816-2020
Official wording
Reason: May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
Code information: Lot Number: 29P6036 UDI: 10886982166913
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw