Biomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter
Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical defect (interference fit) in a surgical implant system, which poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet Spine, LLC is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves, Model No. 8630-0204. The affected lots are TU00052, TU00052A, and TU00117. These sleeves are used with the Timberline MPF System to help establish access into the vertebrae for screws utilized to anchor the plate to the vertebrae.
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 shaft.
The affected products were distributed in the United States to the states of Arizona, California, New York, Tennessee, and Texas, including Puerto Rico. Healthcare providers and facilities should stop using the affected devices and contact Biomet Spine for further instructions.
The recalled product
- Product
- Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized t
- Manufacturer
- Biomet Spine, LLC
- Affected units
- 12
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 8630-0204 Lots TU00052
- TU00052A
- and TU00117
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