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.
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 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 fixa
- 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.
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