16 mm Distraction Pin recall: Sterility Concern
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is…
Why was 16 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# MDS9091616T; Lot #132638
- Product
- 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is…
- Recalling firm
- MEDLINE INDUSTRIES INC
- Quantity
- 198 individual packs
- Distribution
- Nationwide Distribution
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)