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Recall Observatory FDA recall evidence

Device product

16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 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.

Z-0755-2019

December 28, 2018

Class II

Product summary

Firm
Fetzer Medical GmbH & Co. KG
Event
Event 81873
Status
Terminated
Classification
Class II
Quantity
174 units
Official record key
device-enforcement:Z-0755-2019

Official wording

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

Code information: Lot Numbers: 17302220, 17303061, 17303062 and 17303063

Distribution pattern: US Distribution to states of: IL and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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