FDAClass IIJune 27, 2018

Farabeuf Clamp for 3.5mm Screws PRO recall

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Why was Farabeuf Clamp for 3.5mm Screws PRO recalled?

Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm

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?

Lot # 04857V

Product
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Recalling firm
Stryker GmbH
Quantity
18 parts (10 parts quarantined)
Distribution
AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
Recall date
June 27, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls