Recall Z-0756-2019— Fetzer Medical GmbH & Co. KG
Class II · Terminated
Class II FDA medical device recall by Fetzer Medical GmbH & Co. KG, initiated 2018-12-28, terminated 2020-09-17. It names one FDA 510(k) clearance: K172661. Product: 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 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: The firm had a report of doctors being unable to pull the obstetric forceps apart..
- Recalling firm
- Fetzer Medical GmbH & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-28
- Terminated
- 2020-09-17
- Firm location
- Tuttlingen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.