Recall Z-0574-2015
Zimmer, Inc. · initiated August 26, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot: L75066
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 spine.per@zimmer.com.
Details
- Recall number
- Z-0574-2015
- Initiated
- August 26, 2013
- Posted by FDA
- December 12, 2014
- Terminated
- February 24, 2015
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 14 devices
- Distribution
- US nationwide distribution.
- Recalling firm
- Zimmer, Inc., Warsaw, IN