FDAClass IISeptember 28, 2016

FPS 35mm x 3.5 mm non-locking screw recall: Labeling Error

FPS 35mm x 3.5 mm non-locking screw

Why was FPS 35mm x 3.5 mm non-locking screw recalled?

Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

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?

Part number - OS326835 Lot number: 10100/269A12-68051

Product
FPS 35mm x 3.5 mm non-locking screw
Recalling firm
Ortho Solutions Inc
Quantity
15
Distribution
US Distribution
Recall date
September 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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