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
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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
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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 |
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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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