Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns
Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose 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 49 individual packs of 10 mm Distraction Pins, Aggressive. The product is a sterile medical device intended for use in anterior cervical fusion procedures as a temporary fixation screw. The recall involves Item # MDS9091010, Lots #133115 and #136754, which were distributed nationwide.
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.
Healthcare providers and facilities that have received these specific lots should stop using the product and contact Medline Industries for further instructions.
The recalled product
- Product
- 10 mm Distraction Pin, Aggressive 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
- Hazard
- Affected units
- 49
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 (3)
- Item# MDS9091010
- Lots #133115
- 136754
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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