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.
Reported: December 17, 2014 Initiated: August 26, 2013 #Z-0574-2015
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 14 devices
- Distribution
- US nationwide distribution.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 14 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0574-2015.
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