FDAClass IIOctober 15, 2014

MaxLock Extreme Mod-Foot Concave Reamer recall

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

Why was MaxLock Extreme Mod-Foot Concave Reamer recalled?

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

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: MFT-074-CC-24; Lot: 3164011

Product
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Recalling firm
Orthohelix Surgical Designs Inc
Quantity
38
Distribution
USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls