FDA Device recall Z-0978-2015
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retrac…
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retrac… by Biomet Spine, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0978-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-22 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Spine |
| Distribution | AZ, CA, NY, PR, TN, TX |
Product
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
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.
Identifiers
| code_info | Model 8630-0204 Lots TU00052, TU00052A, and TU00117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2015%22
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