FDAClass IIMay 24, 2017

14 mm Distraction Pin recall: Sterility Concern

14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed…

Why was 14 mm Distraction Pin recalled?

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item# MDS9091414A; Lots #136190

Product
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed…
Recalling firm
MEDLINE INDUSTRIES INC
Quantity
1031 individual packs
Distribution
Nationwide Distribution
Recall date
May 24, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls