Class 2 Device Recall DePuy Synthes 3.0mm Headless Compression Screws

• Date Initiated by Firm: September 12, 2018
• Create Date: October 24, 2018
• Recall Status: Terminated on April 10, 2020
• Recall Number: Z-0238-2019
• Recall Event ID: 81152
• 510(K)Number: K050636
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118; ; DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
• Code Information: Lot Numbers: L734474
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: 610-719-5450
• Manufacturer Reason for Recall: The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
• FDA Determined Cause: Under Investigation by firm
• Action: The FRIM, DePuy Synthes, sent an URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated 9/12/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory to identify and quarantine the subject product that is still in the original packaging in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section (page 3 of this notification). 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 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 30 business days. A credit note will be issued for the returned items. 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 NOTE: If the Verification Section is completed on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page number three (3) of this notification. 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 all product subject to this recall (removal) have been returned. While processing your returns, please maintain a copy of this notice with th
• Quantity in Commerce: 20
• Distribution: US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
• 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 = HWC and Original Applicant = SYNTHES (USA)