Medline 12 mm Distraction Pin Recalled for Potential Sterility Loss
Medline Industries is recalling 300 packs of 12 mm Distraction Pins because the sterile packaging seal may be compromised, potentially allowing the device to lose sterility.
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 hazard is a potential loss of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medline Industries, Inc. is recalling 300 individual packs of 12 mm Distraction Pins, Blunt (Item# MDS9091212B, Lot #136780). These sterile medical devices are designed for use in Anterior Cervical Fusion Procedures as temporary fixation screws during cervical spine surgery. The products were distributed nationwide.
The recall was initiated due to a non-conformity involving the integrity of the seal in the sterile packaging. The source text indicates that the seal may have been compromised, which could result in a loss of sterility for the medical device contained within the packaging.
Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Medline Industries for further instructions on the recall process.
The recalled product
- Product
- 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
- Manufacturer
- MEDLINE INDUSTRIES INC
- Affected units
- 300
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)
- Item# MDS9091212B
- Lots #136780
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by MEDLINE INDUSTRIES INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES INC
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26
Similar recalls
- HighTeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
- HighTeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2020-03-25
- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15
- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
FDA (Devices) · 2020-07-15
- SevereMedline Nerve Block Trays Recalled Over Sterilization Calibration Issues
FDA (Devices) · 2026-02-25