Biomet Spine Recalls Anchored Lateral Retractable Drills Due to Sizing Defect
Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.
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 issue without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet Spine, LLC is recalling 15 units of the Anchored Lateral Retractable Drill, Model 8630-0102. These devices are used with the Timberline MPF System to establish access into the vertebrae for screws that anchor plates to the vertebrae.
The recall is due to a manufacturing defect where the outer diameter of the drill shaft is oversized. This results in an interference fit when the drill is inserted into the Fixed or Variable Sleeve Assembly.
The affected units were distributed in Puerto Rico and the states of New York, Arizona, Tennessee, Texas, and California. The specific lots involved are TU00049 (dated February 25, 2013) and TU00155 (dated July 31, 2013). Healthcare facilities should stop using these devices and contact Biomet Spine for instructions on return or replacement.
The recalled product
- Product
- Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
- Manufacturer
- Biomet Spine, LLC
- Affected units
- 15
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 (3)
- Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25
- 2013 and TU00155: July 31
- 2013
Distribution
Related recalls
Same manufacturer · Biomet Spine, LLC
See all →- ModerateBiomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle
FDA (Devices) · 2016-04-06
- ModerateBiomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error
FDA (Devices) · 2015-11-11
- ModerateBiomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall
FDA (Devices) · 2015-09-16
- ModerateBiomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues
FDA (Devices) · 2015-09-16
- HighBiomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength
FDA (Devices) · 2015-07-29
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- ModerateBiomet Spine Recalls Timberline Anchored Lateral Fixed Retractable Sleeves
FDA (Devices) · 2015-01-21
- HighBiomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter
FDA (Devices) · 2015-01-21
- ModerateBiomet Spine Recalls Timberline Cranial Caudal and Posterior Blades
FDA (Devices) · 2015-02-18
- ModerateVertebral Technologies Recalls InterFuse Tail Traction Tool Due to Fit Issues
FDA (Devices) · 2017-02-15
- ModerateBiomet Recalls Torque Limiting Handles for Spinal Fixation Devices
FDA (Devices) · 2015-04-29
- ModerateLanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect
FDA (Devices) · 2013-12-04