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Terminated

Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

FDA Recall Z-0983-2015 · Posted 2015-01-15

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeOVD
Date Initiated2013-08-22
Date Terminated2015-03-13
Product Quantity14 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.

Firm Action

The firm, Lanx, sent a letter to their Consignees/customers dated October 15, 2013. The letter describes the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with conforming product. Please contact Chief Compliance Officer at 303-501-8534 or by email: [email protected] if you have any questions regarding this recall.

Root Cause

Device Design

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.

K123767LANX FUSION SYSTEM- SALanx, Inc. · 2013-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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