FDAClass IINovember 30, 2016

3.0 mm Guide Rod/950 mm with Smooth Tip recall

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

Why was 3.0 mm Guide Rod/950 mm with Smooth Tip recalled?

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

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?

Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756

Product
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Recalling firm
Synthes (USA) Products LLC
Quantity
319 units
Distribution
Distributed Nationwide
Recall date
November 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls