🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 22, 2013 Biomet Spine Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model 8630-0204 Lots TU00052, TU00052A, and TU00117
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biomet Spine, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Model 8630-0204 Lots TU00052, TU00052A, and TU00117

Distribution:

Distributed in: US, AZ, CA, NY, TN, TX, PR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0978-2015

Related Recalls

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Biomet Spine

Class I - Dangerous

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