Device 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.
Z-0574-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 69613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 devices
- Official record key
device-enforcement:Z-0574-2015
Official wording
Reason: 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.
Code information: Lot: L75066
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
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.