Z-0574-2015 Class II Terminated
FDA device recall Z-0574-2015 was initiated by Zimmer, Inc. on Aug 26, 2013 and is designated Class II. 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… The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 14 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 17, 2014
- Initiation Date
- Aug 26, 2013
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 devices
Product Description
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.
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.
Distribution Pattern
US nationwide distribution.
Code Information
Lot: L75066
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0574-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026