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Recall Observatory FDA recall evidence

Device 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.

Z-0983-2015

August 22, 2013

Class II

Product summary

Firm
Biomet Spine, LLC
Event
Event 70070
Status
Terminated
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-0983-2015

Official wording

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.

Code information: LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205

Distribution pattern: US Distribution to states of: AZ, CA, NY, TN and TX including PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.