Class 2 Device Recall De Lee Obstetric Forceps

• Date Initiated by Firm: December 28, 2018
• Date Posted: January 18, 2019
• Recall Status: Terminated on September 17, 2020
• Recall Number: Z-0757-2019
• Recall Event ID: 81873
• 510(K)Number: K172661
• Product Classification: Forceps, surgical, gynecological - Product Code HDA
• Product: 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
• Code Information: Lot Number 18800612
• FEI Number: 3007648354
• Recalling Firm/ Manufacturer: Fetzer Medical GmbH & Co. KG; Unter Buchsteig 5; Tuttlingen Germany
• Manufacturer Reason for Recall: The firm had a report of doctors being unable to pull the obstetric forceps apart.
• FDA Determined Cause: Device Design
• Action: The recalling firm, Fetzer Medical, notified its consignees by email with an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated 12/27/2018 on 12/28/20018. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: 1. Examine your inventory immediately to determine if you have product subject to this action on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. 4. Complete the Reply Form (RF) (Attachment) confirming receipt of this notice and fax this form to Fetzer Medical GmbH & Co. KG, 49 (0) 7462-94799-100 or e-mail the form to dkaufmann@fetzermed.com, without delay, even if you do not have product subject to this recall to return. 5. Keep this notice visibly posted for awareness until all products subject to this recall have been returned to Fetzer Medical. 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. 6. Customers are required to return all affected lots of the affected products that are in their inventory immediately. A replacement of the affected products is not possible, as Fetzer Medical has stopped production of these items. To receive a credit note, please contact Fetzer Medical via contact information below. Only requests submitted before February 1st, 2019 will be considered. 7. To return unused Obstetrical Forceps lots subject to this action, photocopy the completed RF, place it in the box with the product, and send it back to Fetzer Medical. If you have any further questions related to this notice or if you need any additional communications, please contact Fetzer Medical at + 49 (0) 74
• Quantity in Commerce: 10 units
• Distribution: US Distribution to states of: IL and VA.
• 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 = HDA