Recall Z-0756-2019 ยท HDA Forceps, Obstetrical
Fetzer Medical GmbH & Co. KG
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-
| Date | Jan 18, 2019 (initiated Dec 28, 2018) |
| Status | Terminated |
| Reason | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| 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 in |
| Quantity | 10 units |
| Distribution | US Distribution to states of: IL and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172661 | Fetzer Medical Gynecological Forceps Fetzer Medical GmbH & Co. KG, May 8, 2018 |