Z-0758-2019 Class II Terminated
FDA device recall Z-0758-2019 was initiated by Fetzer Medical GmbH & Co. KG on December 28, 2018 and is designated Class II. Reason for recall: The firm had a report of doctors being unable to pull the obstetric forceps apart. The recall status is terminated (terminated September 17, 2020). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 30, 2019
- Initiation Date
- December 28, 2018
- Termination Date
- September 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 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 Pattern
US Distribution to states of: IL and VA.
Code Information
Lot Number 13300956