Z-0448-2016Class II

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

Name: Z-0448-2016 Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or...
Creator: Aesculap, Inc.
Published: 2015-11-10
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2015-11-10 / Terminated / root cause: design

FDA source

Aesculap, Inc. began a recall of Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on... on 2015-11-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0448-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2015-12-16
Terminated: 2016-09-08
Recalling firm: Aesculap Inc
Product: Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.
Product code: LRZ Screwdriver, Surgical
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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: [email protected]., 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: [email protected] 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: [email protected]/Tel: 610-984-9414 or email: [email protected]/Tel: 610-984-9043.
Quantity in commerce: unknown
Distribution: Worldwide Distribution: US (nationwide) and country of: Canada.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0422-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18
Z-0423-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18
Z-0424-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18
Z-0448-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18

Product code LRZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)