Biomet Spine Recalls Timberline Anchored Lateral Fixed Retractable Sleeves
Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical interference fit without reporting any specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet Spine, LLC is recalling 14 units of the Timberline Anchored Lateral Fixed Retractable Sleeve, Model No. 8630-0205. These devices are used with the Timberline MPF System to help establish access into the vertebrae for screws that anchor a plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this sleeve.
The recall is due to a manufacturing defect where the inner diameter of the sleeve shaft is undersized. This results in an interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the sleeve.
The affected units were distributed in the United States to the states of Arizona, California, New York, Tennessee, and Texas, as well as Puerto Rico. The specific lot numbers involved are TU00053A, TU00053B, and TU00118. The product code is 8630-0205.
The recalled product
- 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…
- Manufacturer
- Biomet Spine, LLC
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- LOT Numbers: TU00053A
- TU00053B and TU00118 Product Code: 86300205
Distribution
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