FDA Device recall Z-0983-2015
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205 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-0983-2015 |
| 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 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.
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.
Identifiers
| code_info | LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205 |
|---|
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-0983-2015%22
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