—#131120

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.

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041808
Affected lot / code info: Lot: L75066

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2013-08-26
Posted by FDA: 2014-12-12
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.