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U.S. Department of Health and Human Services

Class 2 Device Recall Title 2 Bone Screw Remover Instrument

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  Class 2 Device Recall Title 2 Bone Screw Remover Instrument see related information
Date Initiated by Firm August 26, 2013
Date Posted December 12, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-0574-2015
Recall Event ID 69613
510(K)Number K041808  
Product Classification spinal implant instrument - Product Code KWP
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.
Code Information Lot: L75066
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Service
866-774-6368
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 14 devices
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ENDIUS, INC.
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