Z-0574-2015Class II

Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover...

Name: Z-0574-2015 Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover...
Creator: Zimmer, Inc.
Published: 2013-08-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-08-26 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial... on 2013-08-26. FDA classified it as Class II and gives the reason as "Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0574-2015
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Posted: 2014-12-12
Terminated: 2015-02-24
Recalling firm: Zimmer GmbH
Product: Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent via e-mail a Zimmer Spine "Medical Device Recall" letter dated August 26, 2013.The letter described the problem and the product affected by the recall. The letter described the "Required Action" to be taken by the consignees. Requested consignees to complete the Verification Section (Appendix A). For questions they can contact Zimmer Spine Customer Service at 1 (866) 774-6368 or [email protected].
Quantity in commerce: 14 devices
Distribution: US nationwide distribution.
Product codes and lots: Lot: L75066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0574-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0574-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code KWP

K041808Class IIEndius Title 2 Polyaxial Spinal SystemEndius, Inc. / cleared 2004-10-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)