Z-0757-2019Class II

16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical...

Name: Z-0757-2019 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical...
Creator: Fetzer Medical GmbH & Co. KG
Published: 2018-12-28
License: https://open.fda.gov/license/

Fetzer Medical GmbH & Co.KG / initiated 2018-12-28 / Terminated / root cause: design

FDA source

Fetzer Medical GmbH & Co. KG began a recall of 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments... on 2018-12-28. FDA classified it as Class II and gives the reason as "The firm had a report of doctors being unable to pull the obstetric forceps apart". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0757-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-28
Posted: 2019-01-18
Terminated: 2020-09-17
Recalling firm: Fetzer Medical GmbH & Co.KG
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.
Product code: HDA Forceps, Obstetrical
Reason for recall: The firm had a report of doctors being unable to pull the obstetric forceps apart.
Root cause tag: design
FDA root 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 [email protected], 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.
Product codes and lots: Lot Number 18800612

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0757-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0755-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18
Z-0756-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18
Z-0757-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18
Z-0758-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18

Product code HDA

K172661Class IIFetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG / cleared 2018-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)