Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw dri

FDA device recall Z-0448-2016 · posted 2015-12-16 · Terminated

Recall details

Recalling firm

Aesculap, Inc.

Reason for recall

The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

Action taken

The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). A replacement for the SJ607R will be sent to you when one becomes available (ME190R). If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.

Root cause

Component design/selection

Status

Terminated

Product code

LRZ

Quantity affected

unknown

Distribution

Worldwide Distribution: US (nationwide) and country of: Canada.

Date initiated

2015-11-10

Date posted

2015-12-16

Date terminated

2016-09-08

Location

Center Valley, PA