Class 2 Device Recall DePuy Synthes

• Date Initiated by Firm: July 21, 2020
• Create Date: August 17, 2020
• Recall Status: Terminated on February 18, 2022
• Recall Number: Z-2816-2020
• Recall Event ID: 86104
• 510(K)Number: K011335
• Product Classification: Plate, fixation, bone - Product Code HRS
• 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
• Code Information: Lot Number: 29P6036 UDI: 10886982166913
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• Manufacturer 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
• FDA Determined 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 DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Return the completed Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 " Send a copy of the completed Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: RA-DPYCH-flactionint@ITS.JNJ.com " Return any subject product within 10 business days. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: RA-DPYCH-flactionint@ITS.JNJ.com 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until the product subject to this action has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. Questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant
• Quantity in Commerce: 191 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)