12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstet

FDA device recall Z-0756-2019 · posted 2019-01-18 · Terminated

Recall details

Recalling firm

Fetzer Medical GmbH & Co. KG

Reason for recall

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

Action taken

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 informed. 3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. 4. Complete the Reply Form (RF) (Attachment) confirming receipt of this notice and fax this form to Fetzer Medical GmbH & Co. KG, 49 (0) 7462-94799-100 or e-mail the form to dkaufmann@fetzermed.com, without delay, even if you do not have product subject to this recall to return. 5. Keep this notice visibly posted for awareness until all products subject to this recall have been returned to Fetzer Medical. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. 6. Customers are required to return all affected lots of the affected products that are in their inventory immediately. A replacement of the affected products is not possible, as Fetzer Medical has stopped production of these items. To receive a credit note, please contact Fetzer Medical via contact information below. Only requests submitted before February 1st, 2019 will be considered. 7. To return unused Obstetrical Forceps lots subject to this action, photocopy the completed RF, place it in the box with the product, and send it back to Fetzer Medical. If you have any further questions related to this notice or if you need any additional communications, please contact Fetzer Medical at + 49 (0) 74

Root cause

Device Design

Status

Terminated

Product code

HDA

Quantity affected

10 units

Distribution

US Distribution to states of: IL and VA.

Date initiated

2018-12-28

Date posted

2019-01-18

Date terminated

2020-09-17

Location

Tuttlingen, Germany

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