Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss
Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device 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 potential loss of sterility in a surgical device, which poses a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, Inc. is recalling 1,031 individual packs of 14 mm Distraction Pins (Item# MDS9091414A, Lot #136190). These sterile medical devices are designed for use in Anterior Cervical Fusion Procedures as temporary fixation screws during cervical spine surgery.
The recall is due to a non-conformity involving the integrity of the sterile packaging seal. It is possible that the seal has been compromised, resulting in a loss of sterility for the medical device contained within. The affected units were distributed nationwide.
Healthcare providers and facilities should stop using these specific devices and contact Medline Industries for further instructions or replacement.
The recalled product
- Product
- 14 mm Distraction Pin, Exagg 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
- 1,031
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# MDS9091414A
- Lots #136190
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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