FDA Devices recall · Reported January 21, 2015
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.
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 R…
Biomet Spine, LLC recalled Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 863… - a moderate-severity action.
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 863… was recalled by Biomet Spine, LLC in January 21, 2015. Reason: The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchor…. Check the official notice for the remedy. Verify recall #Z-0978-2015 with the FDA Devices before acting.
The recall
Biomet Spine, LLC issued this moderate-severity FDA Devices recall-The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchor….
- Moderate
- severity level
- 12 units
- affected scope
- Class II
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0978-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0978-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on August 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet Spine, LLC is listed as the recalling firm, operating out of Broomfield, CO. Federal records list the affected scope as 12 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution to states of: AZ, CA, NY, TN, and TX including PR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product 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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0978-2015 |
| Date reported | January 21, 2015 |
| Date initiated | August 22, 2013 |
| Recalling firm | Biomet Spine, LLC |
| Firm location | Broomfield, CO |
| Affected scope | 12 units |
| Distribution | US Distribution to states of: AZ, CA, NY, TN, and TX including PR. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0978-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026