Medline 16 mm Distraction Pin Recalled Due to Sterile Seal Integrity
Medline Industries is recalling 198 packs of 16 mm Distraction Pins because the sterile packaging seal may be compromised, risking loss of 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 3/5 (High).
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 involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medline Industries, Inc. is recalling 198 individual packs of 16 mm Distraction Pins, Item # MDS9091616T, Lot #132638. These sterile titanium pins are designed for use in anterior cervical fusion procedures as temporary fixation screws. The products were distributed nationwide.
The recall is due to a non-conformity involving the integrity of the seal in the sterile packaging. It is possible that the seal has been compromised, which could result in a loss of sterility for the medical device contained within.
Healthcare providers and facilities should stop using the affected lots and contact Medline Industries for further instructions on returns or replacements.
The recalled product
- Product
- 16 mm Distraction Pin, Titanium, 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
- Hazard
- Affected units
- 198
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# MDS9091616T
- Lot #132638
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 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
- HighMedline Suction Catheters Recalled for Sterilization Error
FDA (Devices) · 2017-11-29
- HighTeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2020-03-25
- HighMedtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues
FDA (Devices) · 2014-11-26