FDA recall Z-0757-2019

Fetzer Medical GmbH & Co. KG · Class II · device

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.

Reason for recall

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Distribution

US Distribution to states of: IL and VA.

Key facts

Status
Terminated
Initiation date
2018-12-28
Report date
2019-01-30
Termination date
2020-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tuttlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0757-2019