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Terminated

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.

FDA Recall Z-0574-2015 · Posted 2014-12-12

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2013-08-26
Date Terminated2015-02-24
Product Quantity14 devices

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.

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041808ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEMEndius, Inc. · 2004-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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