Medline Recalls Distraction Pins Due to Potential Sterility Loss
Medline Industries is recalling 2,112 packs of sterile distraction pins because the packaging seal may be compromised, risking loss of sterility.
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 hazard is a potential loss of sterility due to packaging defects. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medline Industries, Inc. is recalling 2,112 individual packs of 16 mm and 18 mm Distraction Pins. These sterile medical devices are designed for use in anterior cervical fusion procedures as temporary fixation screws. The recall involves specific lots of the 16 mm pins (Item # MDS9091212, Lots #136469 and #136754) and the 18 mm pins (Item # MDS9091818, Lot #136470).
The recall was initiated because the integrity of the seal in the sterile packaging may be compromised. This defect could result in a loss of sterility for the medical device contained within the packaging. The affected products were distributed nationwide.
Healthcare providers and facilities that have received these specific lots of distraction pins should stop using them and contact Medline Industries for further instructions on how to return or dispose of the products.
The recalled product
- Product
- 16 mm [or 18 mm] Distraction Pin, 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 fix
- Manufacturer
- MEDLINE INDUSTRIES INC
- Affected units
- 2,112
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 (5)
- 16 mm Pin: Item# MDS9091212
- Lots #136469
- 136754
- 18 mm Pin: Item# MDS9091818
- Lot #136470
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.
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