Recall Z-0574-2015 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer, Inc.
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.
| Date | Dec 12, 2014 (initiated Aug 26, 2013) |
| Status | Terminated |
| 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. |
| 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 spine.per@zimmer.com. |
| Quantity | 14 devices |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM Endius, Inc., Oct 1, 2004 |