Recall Z-2816-2020 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
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
| Date | Jul 21, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | DePuy Synthes issued Urgent Medical Device Removal letter dated July 21, 2020 stating reason for recall, health risk and action to take: Please take the following actions: 1. Immediately examine your inventory to determine if you have product subject to this action on hand and quarantine the subject product. 2. Complete the attached Verification Section (page 3 of this letter). Please include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. If you have product to be returned: " Call |
| Quantity | 191 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011335 | SYNTHS ONE-THIRD TUBULAR DCL PLATE Synthes (Usa), Jul 27, 2001 |