Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0574-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2013-08-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0574-2015
Date of alert: 2013-08-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0574-2015 — 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.

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