Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endi...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0574-2015.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0574-2015.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0574-2015.
Zimmer, Inc.
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Zimmer, Inc. Recall FAQ
Zimmer, Inc. is the subject of a medical devices safety report: Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endi.... The notice was published on August 26, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 14 units are potentially affected.