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U.S. Department of Health and Human Services

Class 2 Device Recall Telluride Percutaneous Rod Inserter Long

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  Class 2 Device Recall Telluride Percutaneous Rod Inserter Long see related information
Date Initiated by Firm December 19, 2011
Date Posted February 11, 2015
Recall Status1 Terminated 3 on March 23, 2015
Recall Number Z-1089-2015
Recall Event ID 70376
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters.

The Inserter is for use as part of a Telluride System pedicle screw procedure.
Code Information LOT Numbers: L561968 and L570545 Product Code: 7703-1600
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mike Medina
303-501-8548
Manufacturer Reason
for Recall		 The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
FDA Determined
Cause 2		 Device Design
Action Consignees were informally contacted 12/16/2011 of units in the field requesting retrieval. All units were in Lanx's (Biomet's) possession at the time of the recall initiation on 12/19/2011.
Quantity in Commerce 10
Distribution Distributed to TX, OH, NE and NY.
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.
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