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.
FDA Recall Z-0978-2015 · Posted 2015-01-14
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Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeOVD
Date Initiated2013-08-22
Date Terminated2015-03-13
Product Quantity12 units
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.
Firm 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: [email protected].
Root Cause
Component design/selection
Distribution Pattern
US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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