FDAFDA · Food and drugs·Recall number 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 Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.
Published January 21, 2015 · Recall initiated: August 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet Spine, LLC
- Distributor
- US Distribution to states of: AZ, CA, NY, TN and TX including PR.
- Lot
- LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.