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U.S. Department of Health and Human Services

Class 2 Device Recall Timberline Anchored Lateral Variable Retractable Sleeve

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  Class 2 Device Recall Timberline Anchored Lateral Variable Retractable Sleeve see related information
Date Initiated by Firm August 22, 2013
Date Posted January 14, 2015
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-0978-2015
Recall Event ID 70060
510(K)Number K123767  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
Product Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204

Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Code Information Model 8630-0204 Lots TU00052, TU00052A, and TU00117
Recalling Firm/
Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mr. Mike Medina
Manufacturer Reason
for Recall
The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
FDA Determined
Cause 2
Component design/selection
Action The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com.
Quantity in Commerce 12 units
Distribution US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
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 = OVD and Original Applicant = LANX, INC.