Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades
Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.
What this means for you
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 does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm. The recall is due to an oversize of the set screw hex feature.
The affected products are reusable devices provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure. The Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
A total of 213 units were distributed to Texas, Indiana, Missouri, and New York. No foreign, government, military, or VA distribution is reported. The specific models affected are 8734-2XXX and 8734-5XXX, with Lot #L556219.
The recalled product
- Product
- Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with
- Manufacturer
- Biomet Spine, LLC
- Hazard
- Affected units
- 213
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 (20)
- Model #8734-2XXX
- 8734-5XXX. Lot #L556219. Product Code: 8734-2060
- CC Blade
- 60mm 8734-2070
- 70mm 8734-2080
- 80mm 8734-2090
- 90mm 8734-2100
- 100mm 8734-2110
- 110mm 8734-2120
- 120mm 8734-2130
- 130mm 8734-2140
- 140mm 8734-2150
- 150mm 8734-2160
- 160mm 8734-2170
- 170mm 8734-2180
- 180mm 8734-5050
- Posterior Blade
- 50mm 8734-5060
- 60mm 8734-5070
- 70mm 8734-5080
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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12