Z-2816-2020 Class II Terminated
FDA device recall Z-2816-2020 was initiated by Synthes (USA) Products LLC on July 21, 2020 and is designated Class II. Reason for recall: 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 resu… The recall status is terminated (terminated February 18, 2022). Affected quantity: 191 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- July 21, 2020
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 units
Product 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 for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: 29P6036 UDI: 10886982166913