FDA Enforcement
Class II
Terminated
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
Recall: Z-2816-2020
·
Reported August 26, 2020
Enforcement
- Recall Number
- Z-2816-2020
- Event ID
- 86104
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 26, 2020
- Initiation Date
- July 21, 2020
- Classification Date
- August 17, 2020
- Termination Date
- February 18, 2022
- Address
- 1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States
Description
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
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 Info
Lot Number: 29P6036 UDI: 10886982166913
Distribution
US Nationwide distribution.
Quantity
191 units