Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0983-2015 — 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 Retractabl

U.S. FDA — Device Enforcement · United States · 2013-08-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0983-2015
Date of alert: 2013-08-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet Spine, LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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